Two drugs were recently given Priority Review designation by FDA. Obinutuzumab (GA101) was granted Priority Review for the treatment of chronic lymphocytic leukemia, based on final stage 1 data from the pivotal CLL11 trial. The FDA confirmed the action date is December 20, 2013. FDA also granted Priority Review to a pertuzumab (Perjeta) regimen in the neoadjuvant setting for patients with HER2-positive early-stage breast cancer. The FDA will make a decision on approval of pertuzumab by October 31, 2013.
The FDA is evaluating data on obinutuzumab, also known as GA101, from the pivotal phase III CLL11 trial that found obinutuzumab demonstrated a statistically significant 86% reduction in the risk of disease worsening or death (HR = 0.14, 95% CI 0.09-0.21, P < .0001) when combined with chlorambucil chemotherapy compared to chlorambucil alone in previously untreated people with CLL and coexisting medical conditions.
In the CLL11 trial, no new safety signals were detected for obinutuzumab. The most common grade 3/4 adverse events for obinutuzumab were infusion-related reactions and neutropenia, which did not result in an increased risk of infection. The incidence and severity of infusion-related reactions decreased after the first infusion and no grade 3/4 infusion-related reactions have been reported beyond the first infusion.
Obinutuzumab is currently being investigated in multiple phase III studies vs rituximab in indolent non-Hodgkin lymphoma and diffuse large B-cell lymphoma.
Recently FDA also accepted a supplemental Biologics License Application from Genentech for the use of a pertuzumab (Perjeta) regimen in the neoadjuvant setting for patients with HER2-positive early-stage breast cancer. The FDA will make a decision on approval of pertuzumab by October 31, 2013.
The application is based primarily on results from two phase II studies of pertuzumab in HER2-positive early stage breast cancer (NEOSPHERE and TRYPHAENA), as well as on longer-term safety data from the phase III CLEOPATRA study of pertuzumab in HER2-positive metastatic breast cancer. ■