The U.S. Food and Drug Administration (FDA) approved a supplemental application for Opdivo (nivolumab) on October 9, 2015. This approval, designated as BLA 125554 S-5, specifically addressed an efficacy supplement for the drug.
Background
Opdivo (nivolumab) is an immunotherapy drug. This supplemental application, sponsored by Bristol Myers Squibb, focused on demonstrating additional efficacy for the drug, leading to its approval as an efficacy class supplement.
What this means
The FDA's approval of this supplemental application for Opdivo (nivolumab) indicates that new efficacy data supported an expansion or modification of the drug's approved uses. While the specific new indication or patient population is not detailed in the provided information, supplemental approvals typically allow for broader application of the drug based on demonstrated benefits. This allows clinicians to potentially prescribe Opdivo for additional conditions or patient groups where its efficacy has now been formally recognized by the FDA.
Source
The information for this supplemental approval was sourced from the U.S. Food and Drug Administration (FDA). Details regarding the approval of supplemental application BLA 125554 S-5 for Opdivo (nivolumab) were recorded on October 9, 2015, and are publicly accessible on accessdata.fda.gov.