Exact Sciences (Nasdaq: EXAS) today announced the initiation of the pivotal trial for its multi-marker molecular diagnostic screening test for the early detection of colorectal cancer. The multi-center DeeP-C study (Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer) will generate data to support its planned PMA submission to the FDA.
Seattle Genetics Inc. (SGEN) briefing documents for its AdCom meeting on Thursday were released today. Although it has produced impressive efficacy data in trials the FDA noted that the single arm design and small size limits the benefit-risk analysis and that efficacy results are limited to response rates and duration of responses. Time-to-event endpoints such as progression-free survival or overall survival cannot be adequately interpreted in a single arm trial. In addition, a single arm trial does not permit attribution of the adverse events. The panel will vote as to whether Seattle Genetics drug adcetris should have accelerated, regular or no approval for hodgkin lymphoma. The FDA last approved a drug for this indication in 1977.