FDA accepts Genentech's pertuzumab BLA and grants Priority Review

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.

Source: Genentech