FDA Agrees to Review Opdivo for Post-Surgical Melanoma Treatment
Source: Cure Today, March 2023
The Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application to treat Opdivo (nivolumab) in patients with stage 2B or 2C melanoma that has been completely resected (surgically removed), according to Bristol Myers Squibb, the manufacturer of the immunotherapy agent.
A supplemental Biologics License Application is used to request permission to distribute a drug across state lines in the United States. By accepting the application, the FDA also set a goal date of Oct. 13, 2023 to decide on Opdivo’s approval in this indication.
The FDA’s decision was based on findings from the randomized, phase 3 CheckMate-76K trial, which compared 12 months of treatment with Opdivo versus placebo in patients with completely resected stage 2B/C melanoma.