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FDA OKs Roche (RHHBY)'s New Breast Cancer Drug



6/11/2012 7:07:03 AM

Roche Holding AG Monday said the U.S. Food and Drug Administration has approved Perjeta (pertuzumab) in combination with Herceptin and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. MAIN FACTS: This approval is based on data from a Phase III study which showed that people with previously untreated HER2-positive mBC who received the combination of Perjeta, Herceptin and docetaxel chemotherapy lived a median of 6.1 months longer without their cancer getting worse (progression-free survival, or PFS) compared to Herceptin plus docetaxel chemotherapy (median PFS 18.5 vs. 12.4 months).



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