FDA Approves Opdualag for Unresectable or Metastatic Melanoma

On March 18, 2022, FDA approved Bristol-Myers Squibb Company’s Opdualag (nivolumab and relatlimab-rmbw) for use in adults and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. The drug is a fixed-dose combination of the LAG-3-blocking antibody relatlimab and the programmed death receptor-1 blocking antibody nivolumab.

The efficacy of Opdualag was evaluated in a double-blinded trial in 714 patients with previously untreated metastatic or unresectable Stage III or IV melanoma. Patients were randomized to receive 480 mg of nivolumab and 160 mg of relatlimab by intravenous infusion every four weeks or 480 mg of nivolumab by intravenous infusion every four weeks until disease progression or unacceptable toxicity.

FDA granted priority review, fast track designation, and orphan drug designation to Opdualag due to its status as a treatment for a rare disease. The review used FDA’s Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment, according to the press release.