LNTH Lantheus Holdings Inc.

26.51
+0.54  (+2%)
Previous Close 25.97
Open 26.12
52 Week Low 10.52
52 Week High 28.7362
Market Cap $1,792,184,611
Shares 67,604,097
Float 46,436,010
Enterprise Value $1,832,982,743
Volume 83,853
Av. Daily Volume 409,782
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Drug Pipeline

Drug Stage Notes
flurpiridaz F 18
Coronary artery disease (CAD)
Phase 3
Phase 3
Phase 3 trial ongoing.
AZEDRA (iobenguane I 131)
Pheochromocytoma
Approved
Approved
FDA approval announced July 30, 2018.
PYLARIFY (piflufolastat F 18)
Prostate cancer
Approved
Approved
FDA Approval announced May 27, 2021.
1095
Prostate Cancer
Phase 2
Phase 2
Phase 2 enrolment has paused due to COVID-19.
Subcutaneous RELISTOR
Chronic pain
Approved
Approved
Approved September 29, 2014.
Oral RELISTOR
Chronic pain
Approved
Approved
Approved July 19 2016.
1404
Help visualize prostate cancer by targeting prostate specific membrane antigen (PSMA)
Phase 3
Phase 3
Phase 3 trial met one of two co-primary endpoints.
DEFINITY (BENEFIT 1)
Left Ventricular Ejection Fraction
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - February 3, 2020.

Latest News

  1. NORTH BILLERICA, Mass., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced today that prostate specific membrane antigen (PSMA) positron emission tomography (PET) imaging with piflufolastat F 18 has been included in recently updated National Comprehensive Cancer Network® (NCCN) Guidelines® for prostate cancer. The NCCN Guidelines® are widely recognized and used as the standard for clinical policy in oncology by clinicians and payors.

    Lantheus' product, PYLARIFY® (piflufolastat F 18…

    NORTH BILLERICA, Mass., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced today that prostate specific membrane antigen (PSMA) positron emission tomography (PET) imaging with piflufolastat F 18 has been included in recently updated National Comprehensive Cancer Network® (NCCN) Guidelines® for prostate cancer. The NCCN Guidelines® are widely recognized and used as the standard for clinical policy in oncology by clinicians and payors.

    Lantheus' product, PYLARIFY® (piflufolastat F 18) injection, is a radioactive diagnostic agent indicated for PET imaging of PSMA positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy and/or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. PYLARIFY was approved by the U.S. Food and Drug Administration (FDA) in May 2021 and remains the first and only commercially available PSMA-targeted PET imaging agent for prostate cancer.

    Prostate cancer is the second most common form of cancer affecting men in the United States and an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, almost 250,000 new cases of prostate cancer will be diagnosed, and more than 30,000 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.1

    "We are extremely pleased that the NCCN panel of prostate cancer experts, who are dedicated to high-quality, high-value, patient-centered cancer care, have added PSMA-targeted PET imaging with piflufolastat F 18 in unfavorable intermediate, high and very high risk as well as recurrent disease to the updated 2021 guidelines, for the management of prostate cancer," said Bela Denes, MD, Vice President of Medical Affairs of Lantheus. "In addition to FDA approval, inclusion in the guidelines further validates PYLARIFY's performance and utility and will raise awareness within the medical community and payors of the potential impact of this novel PSMA-targeted imaging agent in the care of men with prostate cancer."

    The NCCN® is a not-for-profit alliance of 31 leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. By defining and advancing high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers around the world. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine.

    About PYLARIFY® (piflufolastat F 18) Injection

    PYLARIFY® (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.2-7

    PYLARIFY® (piflufolastat F 18) Injection

    Indication

    PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

    • with suspected metastasis who are candidates for initial definitive therapy.
    • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

    Important Safety Information

    Contraindications

    None.

    Warnings and Precautions

    Risk of Image Misinterpretation

    Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

    Hypersensitivity Reactions

    Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

    Radiation Risks

    Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

    Adverse Reactions

    The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

    Drug interactions

    Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

    To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    For important risk and use information about PYLARIFY Injection, please see Full Prescribing information.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find Fight and Follow® serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate," "believe," "confident," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) the Company's ability to successfully launch PYLARIFY as a commercial product, including (A) Lantheus' ability to obtain FDA approval for additional PET manufacturing facilities (PMFs) that could manufacture PYLARIFY, (B) the ability of those PMFs to supply PYLARIFY to customers, and (C) Lantheus' ability to sell PYLARIFY to customers; and (ii) the risks and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q), including, but not limited to those related to PYLARIFY.

    1American Cancer Society. Facts & Figures 2021. American Cancer Society. Atlanta, GA. 2021.

    2Tan N, Oyoyo U, Bavadian N, et al. PSMA-targeted radiotracers versus 18F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: a systematic review and meta-analysis. Radiology. 2020;296:44-55. doi:10.1148/radiol.2020191689

    3Mena et al. 18 F-DCFPyL PET/CT Imaging in Patients with Biochemically Recurrent Prostate Cancer After Primary Local Therapy J Nucl Med 2020 Jun;61(6):881-889. doi: 10.2967/jnumed.119.234799. Epub 2019 Nov 1.

    4Alipour et al. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019; 11: 1758835919876828.

    5Werner et al 18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging Theranostics 2020; 10(1):1-16. doi:10.7150/thno.37894.

    6Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):1-8. doi:10.1186/s40644-020-0290

    7PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company

    Contacts:

    Mark Kinarney

    Senior Director, Investor Relations

    978-671-8842

    ir@lantheus.com 

    Melissa Downs

    Director, Corporate Communications

    646-975-2533

    media@lantheus.com

     



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  2. NORTH BILLERICA, Mass. and HAYWARD, Calif., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus) and RefleXion Medical, Inc., today announced a development and commercialization collaboration to evaluate the use of piflufolastat F 18, Lantheus' prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent, to enable real-time therapeutic guidance of biology-guided radiotherapy1 (BgRT) in prostate cancer using the RefleXion X1™ platform.

    Lantheus is an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions. RefleXion is a…

    NORTH BILLERICA, Mass. and HAYWARD, Calif., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus) and RefleXion Medical, Inc., today announced a development and commercialization collaboration to evaluate the use of piflufolastat F 18, Lantheus' prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent, to enable real-time therapeutic guidance of biology-guided radiotherapy1 (BgRT) in prostate cancer using the RefleXion X1™ platform.

    Lantheus is an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions. RefleXion is a therapeutic oncology company pioneering BgRT as a new modality for treating all stages of cancer.

    "Combining BgRT with piflufolastat F 18 to detect metastasis in prostate cancer is a promising advancement that may improve patient outcomes," said Jeffrey Wong, MD, Professor of Radiation Oncology at the City of Hope Cancer Center. "Piflufolastat F 18 helps provide an accurate understanding of the location and extent of disease, which is key to creating an effective treatment plan. The potential of RefleXion's BgRT to interpret that reliable location information and guide precise radiotherapy delivery in real-time is unprecedented."

    The RefleXion X1 is the first platform that integrates PET technology into a therapeutic radiation delivery device to enable radiation to be guided in real-time to tumor sites localized by the PET tracer. This approach has the potential to use the tumor's biology, as characterized by the PET tracer, to guide radiation delivery to multiple cancer sites within a patient in a single session. The RefleXion X1 technology has potential advantages over conventional radiotherapy, as it may, when fully realized, enable treatment of more tumors per session, increase accuracy of radiation delivery to tumor sites and reduce toxicity to healthy tissue, and facilitate treatment of more widespread disease than is practical or tolerable with conventional radiotherapy.2 PET PSMA, as a highly sensitive and specific approach to localizing prostate cancer in tumor, lymph nodes, and distant metastatic sites, offers unique potential to bring the promise of RefleXion's novel technology to prostate cancer therapy.

    "By combining the sensitivity and specificity of piflufolastat F 18 with the potential of our BgRT for treating local, regional and metastatic prostate cancer, we expect to have the future ability to address prostate cancer patients in a very specific, highly precise manner," said Thorsten Melcher, Ph.D., Chief Business Officer at RefleXion. "This new customized approach is uniquely enabled by RefleXion's BgRT technology, which could unlock the potential of PET radiotracers, such as piflufolastat F 18, to provide real-time therapeutic guidance."

    The Development and Commercial Collaboration Agreement, which will be managed by a Joint Steering Committee, is focused on obtaining approval to treat patients with BgRT guided by piflufolastat F 18 in the United States. Under the terms of the agreement, Lantheus will contribute to the cost of RefleXion's registrational program. Additionally, the parties will share in the upside created by this collaboration. Further terms of the agreement were not disclosed.

    "Lantheus is committed to advancing and expanding our PSMA platform with innovative solutions to find, fight and follow cancer," said Etienne Montagut, Chief Business Officer at Lantheus. "We are excited to potentially expand the use of piflufolastat F 18 through this collaboration with RefleXion with the goal of improving treatment options for prostate cancer patients."

    About Piflufolastat F 18 Injection

    Piflufolastat F 18 injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, piflufolastat F 18 PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope6 for superior diagnostic performance. The recommended piflufolastat F 18 dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.3-8

    About Prostate Cancer

    Prostate cancer is the second most common form of cancer affecting men in the United States -- an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, almost 250,000 new cases of prostate cancer will be diagnosed, and more than 30,000 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.9

    PYLARIFY® (piflufolastat F 18) Injection

    Indication

    PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

    • with suspected metastasis who are candidates for initial definitive therapy.
    • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

    Important Safety Information

    Contraindications

    None.

    Warnings and Precautions

    Risk of Image Misinterpretation

    Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

    Hypersensitivity Reactions

    Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

    Radiation Risks

    Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

    Adverse Reactions

    The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

    Drug interactions

    Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

    To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    For important risk and use information about PYLARIFY Injection, please see Full Prescribing information.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find Fight and Follow® serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.

    About RefleXion Medical, Inc.

    RefleXion is a privately held commercial stage company developing the first biology-guided radiotherapy (BgRT) system, a significant change in strategy from single tumor therapy to the ability to one day treat multiple tumors in the same treatment session in cancers that have metastasized. BgRT incorporates positron-emission tomography imaging data to enable tumors to continuously signal their location. The BgRT technology will synchronize these data with the linear accelerator to direct radiotherapy to tumors with sub-second latency.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "believe," "expect," "intend," "potential," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. Neither Lantheus Holdings, Inc. (Lantheus) nor RefleXion Medical, Inc. (RefleXion) undertake any obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) the timing and potential outcomes of clinical studies evaluating the use of RefleXion X1 with PYLARIFY in BgRT to interpret reliable location information and guide precise radiotherapy delivery to treat prostate cancer; (ii) RefleXion's ability to obtain marketing clearance for the RefleXion X1's use of PYLARIFY in guiding BgRT from the U.S. Food and Drug Administration (FDA), (iii) RefleXion's ability to successfully expand the use of BgRT; (iv) Lantheus' ability to successfully launch PYLARIFY as a commercial product, including (A) Lantheus' ability to obtain FDA approval for additional PET manufacturing facilities (PMFs) that could manufacture PYLARIFY, (B) the ability of those PMFs to supply PYLARIFY to customers, and (C) Lantheus' ability to sell PYLARIFY to customers; and (v) the risk and uncertainties discussed in Lantheus' filings with the Securities and Exchange Commission (including those described in the Risk Factors section in its Annual Reports on Form 10-K and its Quarterly Reports on Form 10-Q).

    Lantheus Contacts:

    Mark Kinarney

    Senior Director, Investor Relations

    978-671-8842

    ir@lantheus.com

    Melissa Downs

    Director, Corporate Communications

    646-975-2533

    media@lantheus.com

    RefleXion Contact:                                

    Amy Cook                

    acook@reflexion.com

    925-200-2125        

    1The RefleXion™ X1 is cleared for SBRT/SRS/IMRT. BgRT is limited by U.S. law to Investigational use.

    2 Shirvani SM, Huntzinger CJ, Melcher T, Olcott PD, Voronenko Y, Bartlett-Roberto J, et al. Biology-guided radiotherapy: redefining the role of radiotherapy in metastatic cancer. Br J Radiol 2020; 94: 20200873.

    3Mena et al. 18 F-DCFPyL PET/CT Imaging in Patients with Biochemically Recurrent Prostate Cancer After Primary Local Therapy J Nucl Med 2020 Jun;61(6):881-889. doi: 10.2967/jnumed.119.234799. Epub 2019 Nov 1.

    4Alipour et al. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019; 11: 1758835919876828.

    5Werner et al 18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging Theranostics 2020; 10(1):1-16. doi:10.7150/thno.37894.

    6Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):1-8. doi:10.1186/s40644-020-0290-

    7Tan N, Oyoyo U, Bavadian N, et al. PSMA-targeted radiotracers versus 18F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: a systematic review and meta-analysis. Radiology. 2020;296:44-55. doi:10.1148/radiol.2020191689

    8PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company

    9American Cancer Society. Facts & Figures 2021. American Cancer Society. Atlanta, GA. 2021.



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  3. Highlights Piflufolastat F 18's Potential to Change Initial Risk Assessment and Intended Patient Management in High-Risk Prostate Cancer

    Identified Regional Lymph Node and/or Distant Metastases in 26.9% of Patients Prior to Definitive Therapy

    NORTH BILLERICA, Mass., Sept. 10, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced that data from the OSPREY pivotal trial on the utility of piflufolastat F 18 (previously referred to as 18F-DCFPyL or PyL) during initial assessment on men with high risk…

    Highlights Piflufolastat F 18's Potential to Change Initial Risk Assessment and Intended Patient Management in High-Risk Prostate Cancer

    Identified Regional Lymph Node and/or Distant Metastases in 26.9% of Patients Prior to Definitive Therapy

    NORTH BILLERICA, Mass., Sept. 10, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced that data from the OSPREY pivotal trial on the utility of piflufolastat F 18 (previously referred to as 18F-DCFPyL or PyL) during initial assessment on men with high risk prostate cancer were presented at the 2021 American Urological Association (AUA) Virtual Annual Meeting. Piflufolastat F 18 is Lantheus' prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent.

    The OSPREY study evaluated the diagnostic performance of piflufolastat F 18 PET/CT using a histopathology truth standard in men with newly diagnosed prostate cancer. A single dose of 9 mCi (333 MBq) of piflufolastat F 18 was administered via intravenous injection, followed by PET/CT acquisition 1 to 2 hours thereafter. 268 men with a median PSA 9.7 (range 1.2-125.3, n=267) underwent a piflufolastat F 18 PET/CT scan. After a piflufolastat F 18 PET/CT scan, 72 (26.9%) patients had regional lymph node and/or distant metastases identified and were radiographically staged with 39 (14.6%) as N1/M0 and 33 (12.3%) as N0/M1 or N1/M1 disease.

    In addition, the Company also presented at the meeting the results of an independent, retrospective review to assess the impact of piflufolastat F 18 imaging on the planned management of the patients in the trial. A multidisciplinary panel, consisting of an independent urologist, medical oncologist and radiation oncologist, assessed the patients' clinical profiles and conventional imaging data before reviewing the patients' piflufolastat F 18 imaging data. Incorporation of the piflufolastat F 18 results led to a potential change in planned management for 43.6% (115/264) of patients. In 39.0% (103/264), a change in surgery or type of surgery was recommended and in 25.8% (68/264), a change in planned radiation therapy was recommended.1

    "In the OSPREY trial, in patients selected for radical prostatectomy, piflufolastat F 18 was able to detect disease outside of the prostate in nearly one-third of the cases," said Peter Carroll, MD, MPH, Professor of Urology at University of California San Francisco. "These results suggest that PSMA imaging may have a substantial impact on management decisions at the time of initial assessment in men at risk for metastasis."

    "Proper patient selection for any therapy is critical," said Bela Denes, MD, Vice President of Medical Affairs at Lantheus. "This analysis of the OSPREY data further supports the utility of piflufolastat F 18 in men with suspected metastasis prior to definitive therapy and its potential impact on treatment recommendations."

    OSPREY Phase 2/3 Trial

    The OSPREY trial was designed to assess the diagnostic performance of piflufolastat F 18 to detect prostate cancer in pelvic lymph nodes in subjects with high-risk, locally advanced prostate cancer (Cohort A). The primary endpoints for the trial were sensitivity and specificity of piflufolastat F 18 PET/CT imaging to detect metastatic prostate cancer within the pelvic lymph nodes relative to histopathology in Cohort A.

    OSPREY enrolled a cohort of 268 men with biopsy-proven prostate cancer who were considered candidates for radical prostatectomy and pelvic lymph node dissection. These patients were all considered to have high risk disease based on criteria such as Gleason score, PSA level, and tumor stage. Each patient received a single piflufolastat F 18 PET/CT scan from mid-thigh to skull vertex.

    Three central readers independently interpreted each PET scan for the presence of abnormal piflufolastat F 18 uptake in pelvic lymph nodes in multiple sub-regions, including the common iliac lymph nodes. The readers were blinded to all clinical information. While readers also recorded the presence of piflufolastat F 18 PET-positive lesions in the prostate gland and outside the pelvis, those results were not included in the primary efficacy analysis.

    A total of 252 patients (94%) underwent standard-of-care prostatectomy and template pelvic lymph node dissection and had sufficient histopathology data for evaluation of the pelvic lymph nodes. Surgical specimens were separated into three regions: left hemipelvis, right hemipelvis, and other. For each patient, piflufolastat F 18 PET results and histopathology results obtained from dissected pelvic lymph nodes were compared by surgical region. PET results in locations that were not dissected were excluded from analysis.

    For the 252 evaluable patients, the mean age was 64 years (range 46 to 84 years), and 87% were white. The median serum PSA was 9.3 ng/mL. The total Gleason score was 7 for 19%, 8 for 46%, and 9 for 34% of the patients, with the remainder of the patients having Gleason scores of 6 or 10.

    In the trial, the diagnostic performance of piflufolastat F 18 in detecting disease in pelvic lymph nodes (Cohort A) was compared with histopathology. When matched by lymph node location, piflufolastat F 18 showed specificity of 95-98%, sensitivity of 28-39%, and positive predictive value (PPV) of 72-81% meeting the specificity but not the pre-established sensitivity co-primary endpoint.

    Safety results showed piflufolastat F 18 was well tolerated. The most frequent adverse events reported were dysgeusia (2.6%), headache (1.8%) and fatigue (1.3%).2

    About Prostate Cancer

    Prostate cancer is the second most common form of cancer affecting men in the United States -- an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, almost 250,000 new cases of prostate cancer will be diagnosed, and more than 30,000 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.3

    About PYLARIFY® (piflufolastat F 18) Injection

    PYLARIFY (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.4-9

    PYLARIFY® (piflufolastat F 18) Injection

    Indication

    PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

    • with suspected metastasis who are candidates for initial definitive therapy.
    • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

    Important Safety Information

    Contraindications

    None.

    Warnings and Precautions

    Risk of Image Misinterpretation

    Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

    Hypersensitivity Reactions

    Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

    Radiation Risks

    Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

    Adverse Reactions

    The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

    Drug interactions

    Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

    To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    For important risk and use information about PYLARIFY Injection, please see Full Prescribing information.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find Fight and Follow® serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate," "believe," "confident," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) the Company's ability to successfully launch PYLARIFY as a commercial product, including (A) Lantheus' ability to obtain FDA approval for additional PET manufacturing facilities (PMFs) that could manufacture PYLARIFY, (B) the ability of those PMFs to supply PYLARIFY to customers, and (C) Lantheus' ability to sell PYLARIFY to customers; and (ii) the risks and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q), including, but not limited to those related to PYLARIFY.

    1Changes in treatment plan do not necessarily lead to improved patient outcomes.

    2Pienta KJ et al. A Phase 2/3 Prospective Multicenter Study of the Diagnostic Accuracy of Prostate Specific Membrane Antigen PET/CT with 18F-DCFPyL in Prostate Cancer Patients (OSPREY). J Urol. 2021;206(1):52-61.

    3American Cancer Society. Facts & Figures 2021. American Cancer Society. Atlanta, GA. 2021.

    4Mena et al. 18 F-DCFPyL PET/CT Imaging in Patients with Biochemically Recurrent Prostate Cancer After Primary Local Therapy J Nucl Med 2020 Jun;61(6):881-889. doi: 10.2967/jnumed.119.234799. Epub 2019 Nov 1.

    5Alipour et al. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019; 11: 1758835919876828.

    6Werner et al 18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging Theranostics 2020; 10(1):1-16. doi:10.7150/thno.37894.

    7Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):1-8. doi:10.1186/s40644-020-0290-

    8Tan N, Oyoyo U, Bavadian N, et al. PSMA-targeted radiotracers versus 18F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: a systematic review and meta-analysis. Radiology. 2020;296:44-55. doi:10.1148/radiol.2020191689

    9PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company

    Contacts:

    Mark Kinarney

    Senior Director, Investor Relations

    978-671-8842

    ir@lantheus.com

    Melissa Downs

    Director, Corporate Communications

    646-975-2533

    media@lantheus.com

     



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  4. NORTH BILLERICA, Mass., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, today announced Mary Anne Heino, President and Chief Executive Officer, and Bob Marshall, Chief Financial Officer and Treasurer, will present at the following investor conferences.

    • Wells Fargo 2021 Virtual Healthcare Conference
      September 9, 2021 at 4 p.m. ET
    • Baird 2021 Global Healthcare Conference
      September 15, 2021 at 7:55 a.m. ET

    To access a live webcast of the presentation, please visit the Investors section of the Company's…

    NORTH BILLERICA, Mass., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, today announced Mary Anne Heino, President and Chief Executive Officer, and Bob Marshall, Chief Financial Officer and Treasurer, will present at the following investor conferences.

    • Wells Fargo 2021 Virtual Healthcare Conference

      September 9, 2021 at 4 p.m. ET

    • Baird 2021 Global Healthcare Conference

      September 15, 2021 at 7:55 a.m. ET

    To access a live webcast of the presentation, please visit the Investors section of the Company's website at www.lantheus.com. A replay of the webcast will be available on the Company's website for 30 days following the live presentation.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find Fight and Follow® serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.

    Contacts:

    Mark Kinarney

    Senior Director, Investor Relations

    978-671-8842

    ir@lantheus.com

    Melissa Downs

    Director, Corporate Communications

    646-975-2533

    media@lantheus.com



    Primary Logo

    View Full Article Hide Full Article
  5. aPROMISE was developed to quantify and standardize assessment of PSMA PET/CT images and will support PYLARIFY® (piflufolastat F 18) adoption in the U.S.

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus) announced today that its subsidiary, EXINI Diagnostics AB, was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its digital application, aPROMISE™ (automated PROstate Cancer Molecular Imaging Standardized Evaluation). Clinicians will have the option to utilize aPROMISE with PYLARIFY® (piflufolastat F 18) to increase the efficiency and reproducibility of their PSMA PET/CT assessments. PYLARIFY was recently approved by the FDA and is the first and only commercially available PSMA-targeted PET imaging agent for prostate…

    aPROMISE was developed to quantify and standardize assessment of PSMA PET/CT images and will support PYLARIFY® (piflufolastat F 18) adoption in the U.S.

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus) announced today that its subsidiary, EXINI Diagnostics AB, was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its digital application, aPROMISE™ (automated PROstate Cancer Molecular Imaging Standardized Evaluation). Clinicians will have the option to utilize aPROMISE with PYLARIFY® (piflufolastat F 18) to increase the efficiency and reproducibility of their PSMA PET/CT assessments. PYLARIFY was recently approved by the FDA and is the first and only commercially available PSMA-targeted PET imaging agent for prostate cancer.

    aPROMISE is an artificial intelligence-based, medical device software that uses a deep learning algorithm trained and validated across over 3,000 PSMA images to date, to allow healthcare professionals and researchers to perform quantitative assessment of PSMA PET/CT images in prostate cancer. The PROMISE criteria were developed by leading experts in prostate cancer imaging to standardize quantitative evaluation of prostate cancer lesions by location using prostate-specific membrane antigen (PSMA) PET/CT.1 aPROMISE facilitates rapid and robust quantification of prostate cancer lesions in anatomical context, enabling clinicians to make routine use in the clinic of a comprehensive, automated approach to patient evaluation. aPROMISE includes a solution for automated body segmentation and marking, quantifying and reporting suspicious lesions in their anatomical context. aPROMISE provides enhanced consistency in quantitative analysis and standardized reports and has demonstrated increased efficiency and reproducibility of clinicians' PSMA PET/CT image assessments.2,3

    "Lantheus is pleased with the FDA clearance of aPROMISE, our AI-enabled digital application that expands our PSMA platform," said Etienne Montagut, Chief Business Officer for Lantheus. "We are excited to provide such an innovative tool for PSMA quantification and reporting that can empower clinicians to make more informed treatment decisions for their prostate cancer patients."

    aPROMISE Indications for Use

    aPROMISE is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.

    About Prostate Cancer

    Prostate cancer is the second most common form of cancer affecting men in the United States -- an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, almost 250,000 new cases of prostate cancer will be diagnosed, and more than 30,000 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.4

    About PYLARIFY® (piflufolastat F 18) Injection

    PYLARIFY® (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope5 for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.6-10

    PYLARIFY® (piflufolastat F 18) Injection

    Indication

    PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

    • with suspected metastasis who are candidates for initial definitive therapy.
    • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

    Important Safety Information

    Contraindications

    None.

    Warnings and Precautions

    Risk of Image Misinterpretation

    Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

    Hypersensitivity Reactions

    Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

    Radiation Risks

    Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

    Adverse Reactions

    The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

    Drug interactions

    Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

    To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    For important risk and use information about PYLARIFY Injection, please see Full Prescribing information.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find Fight and Follow® serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate," "believe," "confident," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) the Company's ability to successfully launch aPROMISE as a commercial product; (ii) the market receptivity to aPROMISE as a new digital application; (iii) the intellectual property protection of aPROMISE; (iv) interruptions or performance problems associated with our digital application, including a service outage; (v) a network or data security incident that allows unauthorized access to our network or data or our customers' data; and (vi) the risks and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q), including, but not limited to those related to PYLARIFY.

    1Eiber M, Herrmann K, Calais J, Hadaschik B, Giesel FL, Hartenbach M, et al. Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE): Proposed miTNM Classification for the Interpretation of PSMA-Ligand PET/CT. Journal of nuclear medicine: official publication, Society of Nuclear Medicine. 2018;59(3):469-78.

    2Nickols N, Anand A, Johnsson K, Brynolfsson J, Borrelli P, Juarez J, et al. aPROMISE: A Novel Automated-PROMISE platform to Standardize Evaluation of Tumor Burden in (18)F-DCFPyL (PSMA) images of Veterans with Prostate Cancer. Journal of nuclear medicine: official publication, Society of Nuclear Medicine. May 2021.

    3Johnsson K, Brynolfsson J, Sahlstedt H, Nickols N, Rettig M, Probst S, Morris M, Bjartell A, Eiber M, Anand A, Analytical Performance of aPROMISE: Automated Anatomic Contextualization, Detection and Quantification of [18F]DCFPyL (PSMA) Imaging for Standardized Reporting: official Publication, EJNMMI. July 2021

    4American Cancer Society. Facts & Figures 2021. American Cancer Society. Atlanta, GA. 2021.

    5Tan N, Oyoyo U, Bavadian N, et al. PSMA-targeted radiotracers versus 18F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: a systematic review and meta-analysis. Radiology. 2020;296:44-55. doi:10.1148/radiol.2020191689

    6Mena et al. 18 F-DCFPyL PET/CT Imaging in Patients with Biochemically Recurrent Prostate Cancer After Primary Local Therapy J Nucl Med 2020 Jun;61(6):881-889. doi: 10.2967/jnumed.119.234799. Epub 2019 Nov 1.

    7Alipour et al. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019; 11: 1758835919876828.

    8Werner et al 18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging Theranostics 2020; 10(1):1-16. doi:10.7150/thno.37894.

    9Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):1-8. doi:10.1186/s40644-020-0290

    10PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company

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