FDA grants Priority Review for Genentech’s cancer immunotherapy atezolizumab in specific type of lung cancer

Treatment targets people with locally advanced or metastatic NSCLC whose disease expresses the protein PD-L1 and who have progressed on or after platinum-containing chemotherapy.

"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, chief medical officer and head of Global Product Development. "The goal of PD-L1 as a biomarker is to identify people most likely to benefit from atezolizumab alone." Atezolizumab was granted Breakthrough Therapy Designation by the FDA in February 2015 for the treatment of people whose NSCLC expresses PD-L1 and whose disease progressed during or after standard treatments (e.g., platinum-based chemotherapy and appropriate targeted therapy for EGFR mutation-positive or ALK-positive disease). Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure that people have access to them through FDA approval as soon as possible. The BLA submission for atezolizumab is based on results from clinical trials including the Phase II BIRCH study, and the FDA will make a decision on approval by 19 OctOBER 2016. A Premarket Application (PMA) is also under review by the FDA for a companion immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics.

This is the second BLA acceptance and priority review for atezolizumab. On 14 March, Genentech announced that the FDA had accepted the company’s BLA and granted Priority Review for atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Atezolizumab is also being studied in a number of other cancers.