The U.S. Food and Drug Administration (FDA) has accepted Genentech’s Biologics License Application (BLA) and granted Priority Review status for atezolizumab for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose cancer expresses the PD-L1 protein, as determined by a test approved by the FDA, and whose disease had progressed during or following platinum-containing chemotherapy.
Atezolizumab (also known as MPDL3280A) is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death ligand 1 (PD-L1). It is currently in clinical trials as an immunotherapy for several types of solid tumors.
“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,” Sandra Horning, M.D., chief medical officer and head of Global Product Development, said in a recent press release. “The goal of PD-L1 as a biomarker is to identify people most likely to benefit from atezolizumab alone.”
In February 2015 the FDA granted Breakthrough Therapy Designation to atezolizumab for the treatment of patients with NSCLC expressing the PD-L1 and whose disease developed during or following standard treatments.
A breakthrough therapy is a drug intended to be used alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition, for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial effects observed early in clinical development.
If a drug is designated as a breakthrough therapy, the FDA will expedite the development and review of such drug. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and the FDA will either grant or deny the request.
The BLA submission for atezolizumab was based on clinical data from the BIRCH study, an open-label, multicenter, single-arm Phase 2 trial that evaluated the safety and efficacy of atezolizumab in 667 patients with locally advanced or metastatic NSCLC whose disease expressed PD-L1. A decision on approval should be made by late October this year. The FDA is also reviewing a Premarket Application (PMA) for a companion immunohistochemistry (IHC) test advanced by Roche Tissue Diagnostics.
On March 14, the FDA accepted Genentech’s BLA and granted Priority Review for atezolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) whose disease progressed during or after platinum-based chemotherapy, or whose disease deteriorated within one year of treatment with platinum-based chemotherapy prior to neoadjuvant surgery or following adjuvant surgery.