Dako, Roche deal
Dako and Roche's Genentech Inc. unit will collaborate on U.S. regulatory submissions for Dako's HercepTest and HER2 FISH pharmDx as companion diagnostics for Genentech's trastuzumab emtansine ( T-DM1) in patients with advanced HER2-positive breast cancer. Roche and Genentech plan to submit an MAA and BLA in 2H12 for T-DM1 to treat HER2-positive metastatic breast cancer (mBC) in previously treated patients. The humanized mAb against EGFR2 (HER2; ErbB2; neu) linked to ImmunoGen's DM1 cytotoxic agent is in Phase III testing for the indication. Details were not disclosed.
In 2010, FDA refused to file a BLA seeking accelerated approval for T-DM1 for third-line treatment of advanced HER2-positive breast cancer. FDA said T-DM1 trials did not meet the standard for accelerated approval because all available treatments approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population (see BioCentury, Aug. 30, 2010). ...