A supplemental application for Opdivo (nivolumab) received efficacy approval from the U.S. Food and Drug Administration (FDA) on 2015-11-23. This approval indicates an expansion of the drug's approved uses or patient population based on new efficacy data.
Background
Nivolumab, marketed as Opdivo, is a drug developed by Bristol Myers Squibb. The FDA's action on 2015-11-23 was a supplemental approval specifically related to the drug's efficacy, signifying an update to its prescribing information.
What this means
The FDA's supplemental efficacy approval for Opdivo (nivolumab) means that the drug's label has been updated to include new evidence of its effectiveness for an additional indication or patient population. This provides clinicians with expanded options for utilizing nivolumab in patient care, based on the data submitted by the sponsor, Bristol Myers Squibb.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA). The approval for supplemental application BLA 125554 S-12 was granted on 2015-11-23, as detailed on accessdata.fda.gov.