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# FDA Approves BMS’ Opdualag for Some Melanomas
- URL: https://www.fdaweb.com/fda-approves-bms-opdualag-for-some-melanomas/
- Published: 2022-03-22T12:00:00.000Z
- Updated: 2026-09-14T17:37:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151425

FDA has approved Bristol Myers Squibb’s Opdualag (nivolumab and relatlimab-rmbw), described as a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a fixed-dose intravenous infusion, for treating adult and pediatric patients age 12 and older with unresectable or metastatic melanoma. The company [says](https://news.bms.com/news/corporate-financial/2022/U.S.-Food-and-Drug-Administration-Approves-First-LAG-3-Blocking-Antibody-Combination-Opdualag-nivolumab-and-relatlimab-rmbw-as-Treatment-for-Patients-with-Unresectable-or-Metastatic-Melanoma/default.aspx?ref=fdaweb.com) the approval was based on the Phase 2/3 RELATIVITY-047 trial that compared Opdualag to nivolumab alone.

The company says the trial met its primary endpoint of progression-free survival and Opdualag more than doubled the median progression-free survival when compared to nivolumab monotherapy.

The application was approved under FDA’s Real-Time Oncology Review pilot program and also was conducted under the agency’s Project Orbis initiative.