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
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