Genentech announced that the FDA has approved Perjeta (pertuzumab) in combination with Herceptin (trastuzumab; Genentech) and docetaxel chemotherapy for the treatment of patients with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.  

Phase 3 data from the international randomized, double-blind, placebo-controlled CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) trial showed the combination of pertuzumab, trastuzumab, and chemotherapy resulted in a median progression-free survival of 18.5 months compared with 12.4 months for trastuzumab and chemotherapy (HR=0.62; P<0.0001). The study also found pertuzumab, trastuzumab, and chemotherapy resulted in a 38% reduction in risk of disease worsening or death compared to those who received trastuzumab and chemotherapy plus placebo (HR=0.62; P<0.0001).

Pertuzumab, a monoclonal antibody, is an HER2-targeted medicine called a HER2 dimerization inhibitor. It is expected to be available in the United States within two weeks.

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