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# FDA Accepts BMS Submission for Expanded Opdivo Use
- URL: https://www.fdaweb.com/fda-accepts-bms-submission-for-expanded-opdivo-use/
- Published: 2016-04-14T12:00:00.000Z
- Updated: 2026-09-14T20:54:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135370

> FDA has accepted a Bristol-Myers Squibb supplemental BLA for Opdivo that seeks approval for an expanded use in patients with classical Hodgkin lymphoma (cHL) after prior therapies. The application includes data from the company’s CheckMate-205 study, which evaluated the drug in cHL patients who have received an autologous stem cell transplant and brentuximab vedotin. Data from this trial are expected to be presented at a medical meeting later this year. The agency has granted the application a priority review.  
>  
> Earlier this year, FDA approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for treating patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. The agency also expanded the use of Opdivo as a single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients. The drug was approved 11/2015 for use in previously untreated patients with BRAF V600 wild-type unresectable or metastatic melanoma.