FDA Accepts Tecentriq sBLA for Priority Review

FDA has accepted a Genentech sBLA and granted priority review for Tecentriq (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for specified people with non-small cell lung cancer. The company says FDA is reviewing the application under the real-time oncology review pilot program and is expected to decide by 12/1.

Genentech says the application is based on disease-free survival results from an interim analysis of the Phase 3 IMpower 010 study, the only Phase 3 study of a cancer immunotherapy to demonstrate positive results in the adjuvant lung cancer setting.

Tecentriq is described as a monoclonal antibody designed to bind with the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. It is indicated for treating non-small cell lung cancer under certain specified conditions.