Tuesday, November 6, 2012

Latest Genentech breast cancer drug, T-DM1, faces FDA decision by Feb. 26

Genentech Inc.'s experimental cancer drug T-DM1 is heading for a Feb. 26 decision date with the Food and Drug Administration.
The South San Francisco-based U.S. subsidiary of Switzerland's Roche Group said Tuesday that the FDA accepted the company's application for T-DM1, or trastuzumab emtansine, for use by women with HER2-positive metastatic breast cancer. By giving the drug "priority review," the FDA will cut four months off its review time, bringing its decision date on approval to Feb. 26.

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