The FDA has accepted Genentech’s Biologics License Application and granted Priority Review for the its product atezolizumab for the treatment of non-small cell lung cancer.
In February 2015, atezolizumab was granted Breakthrough Therapy designation by the FDA, which is aimed at expediting the development and review of certain medicines to make it accessible as quickly as possible to patients in need. The FDA designation was for the treatment of people whose NSCLC expresses PD-L1 and whose disease progressed during or after standard treatments, such as platinum-based chemotherapy and targeted therapy for EGFR mutation-positive or ALK-positive disease.
The recently announced BLA submission was based on the results from the Phase 2 BIRCH clinical trial (NCT02031458), which evaluated the safety and efficacy of atezolizumab in 667 people with locally advanced or metastatic PD-L1-positive NSCLC.
“In a study of atezolizumab in people with previously treated advanced lung cancer, PD-L1 expression correlated with how well they responded to the medicine,” said Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, in a press release. “The goal of PD-L1 as a biomarker is to identify people most likely to benefit from atezolizumab alone.”
Last month, the FDA also accepted Genentech’s BLA and granted Priority Review for atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma.
