T-DM1 gets Priority Review
FDA accepted and granted Priority Review to a BLA from Genentech Inc. for trastuzumab emtansine ( T-DM1) to treat HER2-positive, unresectable locally advanced or metastatic breast cancer in patients who have received prior treatment with Herceptin trastuzumab and a taxane-based chemotherapy regimen. The PDUFA date is Feb. 26, 2013. T-DM1 also is under review in the EU. The product is a humanized mAb against epidermal growth factor receptor 2 ( EGFR2; HER2) linked to the DM1 cytotoxic agent from ImmunoGen Inc. (NASDAQ:IMGN). Genentech, a unit of Roche (SIX:ROG; OTCQX:RHHBY), has rights to use ImmunoGen's TAP antibody-conjugate technology under a 2000 deal. Genentech and ImmunoGen made the announcement late Tuesday. Roche markets Herceptin. ImmunoGen was off $0.06 to $11.38 on Tuesday. ...