Opdualag nivolumab and relatlimab

Drug Class

LAG-3 and PD-1 monoclonal antibody combination

Mechanism

Fixed-dose combination of relatlimab (LAG-3 blocker) and nivolumab (PD-1 blocker), cooperatively releasing T-cell inhibition to enhance antitumor immune responses.

Approved Indication

Unresectable or metastatic melanoma in adult and pediatric patients aged 12 years or older, per its FDA approval.

What This Means For Patients

Opdualag is a combination immunotherapy containing two antibodies (nivolumab and relatlimab) that target distinct immune checkpoint pathways (PD-1 and LAG-3). This dual-action treatment is used for patients with advanced melanoma and is available under special import rules at Lecheng.

Regulatory Approvals

• FDA — approved (2022) — label

Pivotal Clinical Evidence

• RELATIVITY-047 — Tawbi et al., N Engl J Med 2022 (NCT03470922) — DOI

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-opdualag-unresectable-or-metastatic-melanoma
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761234s000lbl.pdf