Genentech's Cancer-Fighting T-DM1 Leads FDA Class of 2013
Published: Jan 02, 2013
Meet the Bay Area's next blockbuster drug: T-DM1, a breast cancer-fighting treatment developed by Genentech Inc., leads the early Class of 2013 drugs seeking Food and Drug Administration approval. The FDA's decision date is Feb. 26. At least 10 drugs developed by Bay Area companies face FDA approval in the first few months of 2013. That is on top of the record 16 Bay Area drugs approved in 2012. To be sure, some of the wannabe therapies may not pass muster with the agency, which weighs clinical trial data to determine safety and efficacy of a drug. But others, like T-DM1, may win approval before their technical decision dates. For example, the FDA three months early approved the prostate cancer drug Xtandi from San Francisco’s Medivation Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. in August. And Onyx Pharmaceuticals Inc. (NASDAQ: ONXX) of South San Francisco won approval July 20 -- a week earlier than expected -- of its multiple myeloma drug Kyprolis. The FDA last month granted T-DM1 "priority review," shaving four months off the agency's review time.