FDA accepts BLA and provides priority review for Tecentriq to treat small cell lung cancer- Genentech/Roche

Genentech has announced that the FDA has accepted the company�s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of people with extensive-stage small cell lung cancer (ES-SCLC). The FDA is expected to make a decision on approval by 18 March 2019. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a serious disease.

�It�s been more than 20 years since there has been a new initial treatment option for extensive-stage small cell lung cancer that delivers a clinically meaningful survival benefit,� said Sandra Horning, M.D., chief medical officer and head of Global Product Development. �We are working closely with the FDA to bring this Tecentriq-based regimen to people with this difficult-to-treat type of lung cancer as soon as possible.�

This sBLA is based on results from the Phase III IMpower133 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with ES-SCLC. The safety profile of the combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified.