FDA and Trastuzumab DM1 no fast track

snowyday

Log in or create a free account for complete access to everything MedPage Today has to offer!

Anti-HER2 Drug Fails to Win FDA Fast Track

By Charles Bankhead, Staff Writer, MedPage Today Published: August 27, 2010 WASHINGTON -- The Food and Drug Administration turned down a request for accelerated approval of Roche-Genentech's trastuzumab-DM1 drug for the treatment of HER2-positive breast cancer. The FDA concluded that the supporting data for trastuzumab-DM1 did not meet the Biologic License Application (BLA) Standard for accelerated approval because all available treatment choices for metastatic breast cancer -- irrespective of HER2 status -- had not been exhausted. Roche had requested accelerated approval on the basis of a single-arm phase II study showing that trastuzumab-DM1 led to tumor responses in a third of patients with advanced HER2-positive breast cancer. Patients in the trial had received an average of seven prior regimens. An ongoing phase III study will continue as planned. In a statement from the company, Roche officials said they expect a global regulatory submission for trastuzumab-DM1 by the middle of 2012. Trastuzumab-DM1 is an antibody-drug conjugate, also known as an armed antibody. Conjugate links trastuzumab with the chemotherapy agent DM1, using a stable linker that keeps the agent in one piece until it reaches its target cancer cells, according to a Roche statement. The antibody is designed to bind and penetrate HER2-positive cancer cells and then release the active drug inside the cells to destroy them. Roche is headquartered in Basel, Switzerland. Genentech, based in San Francisco, Calif., is a unit of Roche. Additional FDA General Coverage »