Genentech, a member of the Roche Group, said Tuesday that the U.S. Food and Drug Administration has accepted the company's Biologics License Application for trastuzumab emtansine and granted priority review.
Trastuzumab emtansine's 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 and a taxane chemotherapy. The FDA confirmed the action date is February 26, 2013.
Roche's Marketing Authorization Application for trastuzumab emtansine for people with HER2-positive mBC has also been accepted for review by the European Medicines Agency.
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