Genentech Breast Cancer Drug Denied Accelerated Approval

Genentech has been denied accelerated approval for its investigational breast cancer treatment trastuzumab-DM1 (T-DM1), a move likely to push the drug’s potential market entry back at least two years. The FDA issued a refuse-to-file letter for the BLA for T-DM1, a combination of Genentech’s Herceptin (trastuzumab) and ImmunoGen’s cancer-killing agent DM1, because all available treatment options for metastatic breast cancer were not exhausted in the study population in trials of the drug, Genentech says. The company will continue its Phase III trial, in which T-DM1 is being compared with GlaxoSmithKline’s Tykerb (lapatinib ditosylate) plus capecitabine for a second-line indication.
Washington Drug Letter