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FDA Brief: Priority Review for Nivolumab Plus Chemotherapy as Neoadjuvant Treatment in Lung Cancer

By: Lauren Velentzas
Posted: Tuesday, March 1, 2022

On February 28, Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) accepted the supplemental biologics license application for the PD-1 inhibitor nivolumab plus chemotherapy for the neoadjuvant treatment of patients with resectable non–small cell lung cancer (NSCLC). Nivolumab-based therapies have been shown to be effective in the neoadjuvant or adjuvant treatment of lung cancer, bladder cancer, esophageal junction cancer, and melanoma.

The filing was made based on the results of the CheckMate 816 trial, in which nivolumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response and event-free survival versus chemotherapy alone when given before surgery. It was the first phase III trial to show such a benefit with an immunotherapy-based combination in the neoadjuvant setting of NSCLC. Results from CheckMate 816 were presented at the 2021 American Association for Cancer Research and the 2021 American Society of Clinical Oncology Annual Meetings.


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