FDA Grants Priority Review to Obinutuzumab in CLL and Pertuzumab in Neoadjuvant Therapy for HER2-positive Early-stage Breast Cancer
Two drugs were given Priority Review designation by FDA earlier this week. Obinutuzumab (GA101) was granted Priority Review for the treatment of chronic lymphocytic leukemia (CLL), based on final stage 1 data from the pivotal CLL11 trial. FDA also granted Priority Review to a pertuzumab (Perjeta) regimen in the neoadjuvant setting for patients with HER2-positive early-stage breast cancer.
Obinutuzumab Review
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 (Leukeran) 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 (Rituxan) in indolent non-Hodgkin lymphoma and diffuse large B-cell lymphoma.
Pertuzumab
Earlier this week, FDA 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.
FDA’s breakthrough therapy designation is designed to expedite the development and review of medicines intended to treat serious and life-threatening diseases and to help ensure people have access to them through FDA approval with a shorter review time. A priority review designation is granted to medicines that the FDA believes have the potential to provide significant improvements in the treatment, prevention, or diagnosis of a disease.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
