The U.S. Food and Drug Administration (FDA) approved a supplemental application for Opdivo (nivolumab) on September 18, 2020. This approval pertains to an efficacy supplement for the drug, sponsored by Bristol Myers Squibb.
Background
Nivolumab, marketed under the brand name Opdivo, is a prescription medicine developed by Bristol Myers Squibb. This supplemental approval specifically addresses an efficacy update for the drug, indicating new data or information regarding its effectiveness.
What this means
The FDA's approval of a supplemental application for Opdivo (nivolumab) for efficacy signifies an update or expansion to the drug's previously approved uses. While the specific new indication or patient population is not detailed in the provided information, such approvals typically reflect new data supporting the drug's effectiveness in an additional context or an improved understanding of its benefits. This provides clinicians with updated prescribing information for nivolumab, potentially broadening its clinical utility.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA). The approval, identified as BLA 125554 S-84, was granted on September 18, 2020, and is publicly accessible on accessdata.fda.gov.