Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application for pertuzumab and granted Priority Review.
Pertuzumab is a humanized monoclonal antibody being studied in early and advanced stages of HER2-positive breast cancer and advanced HER2-positive gastric cancer.
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.
The pertuzumab application is based on results from the Phase 3 Cleopatra study. The study demonstrated a 6.1 month improvement in median progression-free survival for people who received a pertuzumab-based regimen (pertuzumab combined with Herceptin and docetaxel chemotherapy) compared to those who received Herceptin and chemotherapy alone. People who received the combination also experienced a 38% 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% 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%, 13.8% and 7.9% in the pertuzumab, Herceptin and chemotherapy arm compared with 45.8%, 7.6%, and 5% in the Herceptin plus chemotherapy arm. 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% of people in the Herceptin and chemotherapy arm and 4.4% of people in the pertuzumab, Herceptin and chemotherapy arm.
Release Date: Feb. 7, 2012