Trastuzumab emtansine regulatory update

Chugai submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for trastuzumab emtansine to treat HER2-positive metastatic or recurrent breast cancer. The product is a humanized mAb against epidermal growth factor receptor 2 ( EGFR2; HER2) linked to the DM1 cytotoxic agent from ImmunoGen. Roche's Genentech Inc. unit has rights to use ImmunoGen's TAP antibody-conjugate technology under a 2000 deal (see BioCentury, May 8, 2000). Chugai is majority owned by Roche. ...