FDA Grants Priority Review to Atezolizumab Combination for Metastatic Lung Cancer
Posted: Wednesday, May 9, 2018
On May 6, 2018, the U.S. Food and Drug Administration (FDA) accepted Genentech’s supplemental Biologics License Application and granted Priority Review for atezolizumab (Tecentriq), in combination with bevacizumab (Avastin), paclitaxel, and carboplatin, as a first-line treatment for patients with metastatic nonsquamous non–small cell lung cancer (NSCLC).
Atezolizumab is currently approved by the FDA to treat patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy and after an appropriate FDA-approved targeted therapy if their tumor has ALK or EGFR gene abnormalities.
This acceptance is based on results from the IMpower150 study, a multicenter, open-label, randomized, controlled phase III study evaluating the efficacy and safety of atezolizumab in combination with carboplatin and paclitaxel with or without bevacizumab in patients with stage IV nonsquamous NSCLC who had not been treated with chemotherapy for their advanced disease. The study enrolled 1,202 patients, and those with ALK and EGFR mutations were excluded from the primary intention-to-treat analysis.
The co-primary endpoints were overall and progression-free survival, as determined by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1. The primary analysis of the co-primary endpoints in IMpower150 was assessed in all randomized patients without an ALK or EGFR genetic mutation and in a subgroup of people who had the effector T-cell gene signature expression.
