Trastuzumab emtansine regulatory update

Genentech submitted a BLA to FDA for T-DM1 to treat HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Herceptin trastuzumab and a taxane chemotherapy. The Roche unit said it also plans to open an Expanded Access Program in the U.S. to provide T-DM1 to patients with HER2-positive metastatic breast cancer while the company obtains regulatory approval. Roche plans to submit an MAA to EMA for T-DM1 "shortly." T-DM1 is a humanized mAb against epidermal growth factor receptor 2 ( EGFR2; HER2) linked to ImmunoGen's DM1 cytotoxic agent. Genentech has rights to use ImmunoGen's TAP antibody-conjugate technology under a 2000 deal (see BioCentury, May 8, 2000).

In 2010, FDA refused to file a BLA seeking accelerated approval for T-DM1 for third-line treatment of advanced HER2-positive breast cancer. At the time, 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). ...