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FDA Grants Nivolumab/Ipilimumab Plus Chemo Priority Review in Frontline NSCLC

Jason M. Broderick @jasoncology
Published: Wednesday, Apr 08, 2020

Sabine Maier, MD

Sabine Maier, MD

The FDA has granted a priority review designation to nivolumab (Opdivo) plus ipilimumab (Yervoy) and chemotherapy for use as a frontline treatment for patients with metastatic or recurrent non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.1 

The application for the regimen is based on findings from the phase III CheckMate-9LA trial, in which nivolumab plus low-dose ipilimumab given concomitantly with 2 cycles of chemotherapy showed superior overall survival (OS) compared with up to 4 cycles of chemotherapy alone followed by optional maintenance treatment in patients with advanced non–small cell lung cancer.

The FDA is scheduled to decide on the application by August 6, 2020. An application for the same indication has also been accepted by the European Medicines Agency, and approval for the regimen in this setting is also being sought in Japan. 

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