Roche (RHHBY.PK) said the U.S. Food and Drug Administration or FDA has accepted the company's Biologics License Application for pertuzumab and granted Priority Review.
The proposed indication is pertuzumab in combination with Herceptin and docetaxel chemotherapy for people with HER2-positive metastatic or locally recurrent, unresectable breast cancer, who have not received previous treatment or whose disease has relapsed after adjuvant therapy. The FDA confirmed the action date is June 8, 2012.
The pertuzumab application is based on results from the pivotal Phase III CLEOPATRA study. The study showed a 6.1 month improvement in median progression-free survival for people who received a pertuzumab-based regimen compared to those who received Herceptin and chemotherapy alone. Moreover, people who received the combination also underwent a 38 percent reduction in the risk of their disease worsening or death, the company added.
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