FDA accepts Genentech's pertuzumab BLA and grants Priority Review

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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application for pertuzumab and granted Priority Review. The proposed indication is pertuzumab in combination with Herceptin® (trastuzumab) 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.

"We are pleased that the FDA has granted pertuzumab a Priority Review because new medicines are needed for HER2-positive breast cancer," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We have been researching HER2-positive breast cancer for more than 30 years, and we hope an expedited review will help us quickly bring another personalized medicine to people battling this aggressive disease."

The pertuzumab application is based on results from the pivotal Phase III CLEOPATRA study. The study demonstrated a 6.1 month improvement in median progression-free survival (PFS) for people who received a pertuzumab-based regimen (pertuzumab combined with Herceptin and docetaxel chemotherapy) compared to those who received Herceptin and chemotherapy alone (median PFS 18.5 vs. 12.4 months). People who received the combination also experienced a 38 percent reduction in the risk of their disease worsening or death.

Adverse events (AEs) were consistent with those seen in previous studies of pertuzumab and Herceptin, either in combination or alone. Rates of Grade 3 or higher AEs with more than 2 percent difference between arms were observed for neutropenia (low white blood cell count), febrile neutropenia (fever plus low white blood cell count) and diarrhea with 48.9 percent, 13.8 percent and 7.9 percent in the pertuzumab, Herceptin and chemotherapy arm compared with 45.8 percent, 7.6 percent and 5.0 percent in the Herceptin plus chemotherapy arm, respectively. The pertuzumab-based regimen was not associated with a higher incidence of cardiac AEs or left ventricular dysfunction compared with Herceptin and chemotherapy. Left ventricular dysfunction occurred in 8.3 percent of people in the Herceptin and chemotherapy arm and 4.4 percent of people in the pertuzumab, Herceptin and chemotherapy arm.



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