FDA stalls ImmunoGen-linked breast cancer therapy approval
The U.S. Food and Drug Administration has sent a Refuse to File letter to Genentech Inc., which is licensing Targeted Antibody Payload (TAP) technology from Waltham-based ImmunoGen Inc., for accelerated approval of its breast cancer treatment. The Biologic License Application is for the drug trastuzumab-DM1 (T-DM1), which is being developed by Roche Holding AG for treatment of advanced HER2+ breast cancer.
According to a press release  from ImmunoGen, the FDA’s letter indicated that the drug did not qualify for accelerated approval since other possible treatments for metastatic breast cancer were not used in the study.
T-DM1 will continue to be tested in its current Phase 3 clinical trial, where the drug is being compared to another HER2+ breast cancer treatment – lapatinib in combination with capecitabine. The initiation of the Phase 3 trial, announced in March 2009, resulted in a $6.5 million milestone payment  for ImmunoGen (Nasdaq: IMGN) from Genentech and Roche.