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Opdualag FDA Approval History

Last updated by Judith Stewart, BPharm on March 20, 2022.

FDA Approved: Yes (First approved March 18, 2022)
Brand name: Opdualag
Generic name: nivolumab and relatlimab-rmbw
Previous name: relatlimab and nivolumab
Dosage form: Injection
Company: Bristol-Myers Squibb Company
Treatment for: Melanoma

Opdualag (nivolumab and relatlimab-rmbw) is programmed death receptor-1 (PD-1) blocking antibody and lymphocyte activation gene-3 (LAG-3) blocking antibody combination indicated for the treatment of unresectable or metastatic melanoma.

  • Opdualag is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
  • Nivolumab is programmed death receptor-1 (PD-1) blocking antibody first approved under the brand name Opdivo for the treatment of unresectable or metastatic melanoma in 2014.
  • Lymphocyte activation gene-3 (LAG-3) is a cell-surface molecule expressed on effector T cells and regulatory T cells, and is linked with T-cell exhaustion and resistance to immunotherapies such as PD-1 blocking antibodies. Relatlimab is a LAG-3–blocking antibody that works by binding to LAG-3 on T cells, thereby restoring effector function of exhausted T cells and potentially promoting an anti-tumor response.
  • The combination of nivolumab and relatlimab results in increased T-cell activation compared to the activity of either antibody alone.
  • The FDA approval of Opdualag is based on the results of the Phase 2/3 RELATIVITY-047 trial, in which the relatlimab and nivolumab fixed-dose combination demonstrated a statistically significant and clinically meaningful progression-free survival benefit over nivolumab monotherapy.
  • Opdualag is administered every four weeks as a single intravenous infusion over 30 minutes.
  • Opdualag is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions (IMARs) including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, myocarditis and other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); and embryo-fetal toxicity.
  • Common adverse reactions include musculoskeletal pain, fatigue, rash, pruritus, and diarrhea. Common laboratory abnormalities include decreased hemoglobin, decreased lymphocytes, increased AST, increased ALT, and decreased sodium.

Development timeline for Opdualag

Mar 18, 2022Approval FDA Approves Opdualag (nivolumab and relatlimab-rmbw) for the Treatment of Patients with Unresectable or Metastatic Melanoma
Sep 20, 2021U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination as Treatment for Patients with Unresectable or Metastatic Melanoma
Mar 25, 2021Bristol Myers Squibb Announces RELATIVITY-047, a Trial Evaluating Anti-LAG-3 Antibody Relatlimab and Opdivo (nivolumab) in Patients with Previously Untreated Metastatic or Unresectable Melanoma, Meets Primary Endpoint of Progression-Free Survival

Further information

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