ImmunoGen Inc. (IMGN), said Tuesday that Genentech, a part of the Roche Group (RHHBY.PK), has revealed that the U.S. Food and Drug Administration has officially accepted the Biologics License Application 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) and a taxane chemotherapy.
Genentech also disclosed that Roche's Marketing Authorization Application for trastuzumab emtansine for people with HER2-positive metastatic breast cancer has been accepted for review by the European Medicines Agency.
The FDA grants Priority Review designation to drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists. The FDA has assigned this BLA a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2013.
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