FDA Approves Nivolumab/Relatlimab Combo for Unresectable or Metastatic Melanoma


Patients with unresectable or metastatic melanoma can now receive treatment with nivolumab and relatlimab-rmbw following its approval by the FDA.

The FDA has approved a combination of nivolumab and relatlimab-rmbw (Opdualag) for patients with unresectable or metastatic melanoma, according to a press release from the FDA.

The novel, first-in-class, fixed dose regimen was approved based on findings from the phase 2/3 RELATIVITY-047 trial (NCT03470922), which assessed the combination vs single-agent nivolumab. The combination yielded a median PFS of 10.1 months (95% CI, 6.4-15.7) compared with 4.6 months (95% CI, 3.4-5.6) in the monotherapy arm (HR, 0.75; 95% CI, 0.62-0.92; P = .0055).

The FDA approved dosing indicated that patients 12 years or older who weighed 40 kg would receive 480 mg nivolumab and 160 mg relatlimab intravenously every 4 weeks. Those who weighed less than 40 kg or were younger than 12 do not have established dosing information.

Additionally, no new safety findings were identified with nivolumab plus relatlimab vs nivolumab alone. However, the combination is associated with several severe and fatal immune-mediated adverse effects, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, and myocarditis.

“Since the approval of the first immune checkpoint inhibitor more than 10 years ago, we’ve seen immunotherapy, alone and in combination, revolutionize the treatment of patients with advanced melanoma,” F. Stephen Hodi, MD, director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute, said in a press release. “Today’s approval is particularly significant, as it introduces an entirely new combination of 2 immunotherapies that may act together to help improve anti-tumor response by targeting 2 different immune checkpoints—LAG-3 and PD-1.”


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. News release. Bristol Meyers Squibb. March 18, 2022. Accessed September 22, 2022. https://bit.ly/3DNa8a4

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