The FDA has given the green light to Bristol Myers Squibb’s Opdivo for use before and after surgery for non-small cell lung cancer.
A regimen of Opdivo plus chemotherapy before surgery, followed by Opdivo alone after surgery, was approved for certain non-small cell lung cancer patients. Thursday’s approval comes several days ahead of the FDA’s decision deadline of Oct. 8.
Opdivo now joins Merck’s Keytruda and AstraZeneca’s Imfinzi as checkpoint inhibitors available for use before and after surgery to remove lung cancer tumors. It was approved in 2022 as a therapy for patients with platinum-based chemotherapy before lung cancer surgery only.
The FDA has raised concerns over the potential for over-treatment with certain perioperative treatment regimens, which is when therapy is given both before and after surgery. Prior to granting Imfinzi approval before and after lung cancer surgery in August, the agency held an advisory committee meeting, and outside experts recommended that future studies be designed to show how each part of the treatment regimens contributes to therapeutic benefit.
Opdivo’s latest label expansion was granted based on results from the CheckMate -77T study, which showed that the Opdivo regimen reduced the risk of certain negative events like complications, cancer recurrence and progression by 42%, in addition to “no detriment” to overall survival.