Roche, Genentech hit with refuse-to-file letter

The FDA has handed Roche and Genentech a refuse-to-file letter for the developers' BLA for trastuzumab-DM1. The drug attaches ImmunoGen DM1 cancer-cell killing agent to Genentech's HER2-targeting antibody, trastuzumab. Roche submitted the BLA in July following a successful Phase II study in which the drug shrank tumors by one-third in women with late-stage breast cancer. The company had hoped to gain accelerated approval of the drug. The FDA says the T-DM1 trials did not meet the...