FDA Approves Opdivo for Lung Cancer Surgery

The FDA has approved Bristol Myers Squibb’s Opdivo for use both before and after surgery in treating certain patients with non-small cell lung cancer. This decision allows a regimen consisting of Opdivo in combination with chemotherapy prior to surgery, followed by Opdivo alone post-surgery. The approval came several days ahead of the FDA’s scheduled decision deadline of October 8.

With this new approval, Opdivo joins other checkpoint inhibitors such as Merck’s Keytruda and AstraZeneca’s Imfinzi. These medications are now available for use in both the preoperative and postoperative settings for lung cancer tumor removal. Opdivo had already been approved in 2022 for use in patients undergoing platinum-based chemotherapy before lung cancer surgery.

The FDA has expressed concerns regarding the potential for over-treatment with certain perioperative treatment regimens, which involve therapy administered both before and after surgery. Before approving Imfinzi for preoperative and postoperative lung cancer surgery in August, the FDA held an advisory committee meeting. At this meeting, external experts recommended that future studies should be designed to demonstrate the specific contributions of each component of treatment regimens to the overall therapeutic benefit.

The latest expansion of Opdivo's label is based on results from the CheckMate -77T study. This study found that the Opdivo regimen significantly reduced the risk of negative outcomes, such as complications, cancer recurrence, and progression, by 42%. Additionally, the study reported "no detriment" to overall survival, supporting the efficacy of the treatment.