ImmunoGen, Inc. announced that Genentech, a member of the Roche Group, has disclosed that the FDA has officially accepted the Biologics License Application (BLA) for trastuzumab emtansine and granted it Priority Review; the proposed indication is for the treatment of people with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Herceptin (trastuzumab; Genentech) and a taxane chemotherapy. Trastuzumab emtansine is an antibody-drug conjugate (ADC) comprised of the antibody trastuzumab and the chemotherapy DM1 attached together using a stable linker. It is designed to target and inhibit HER2 signaling and deliver the chemotherapy directly inside HER2-positive cancer cells.
The FDA grants Priority Review designation to drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists. For applications granted Priority Review, the FDA’s goal is to complete the review and deliver a decision on marketing approval within six months. The FDA has assigned this BLA a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2013.
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