FDA Approves Opdualag (nivolumab and relatlimab-rmbw) Fixed-Dose Combination as Treatment for Patients with Unresectable or Metastatic Melanoma


Samantha Guild
AIM at Melanoma Foundation

March 19, 2022 (Richmond, California) Yesterday, Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved Opdualag (nivolumab and relatlimab-rmbw) fixed-dose combination treatment for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

FDA approval was based on the phase 2/3 clinical trial called Relativity-047 in which Opdualag showed statistically and clinically meaningful progression-free survival benefit over the monotherapy nivolumab alone. Other combination therapies exist but can cause significant toxicity.

“Opdualag is exciting for patients and physicians alike,” said lead study author Hussein Tawbi, M.D., Ph.D. “Other combinations work well but carry substantial toxicity. It’s wonderful to be able to offer patients an effective and safer option for treatment.”

“Side effects can be extremely challenging for melanoma patients,” said Samantha Guild, president of AIM at Melanoma. “This new combination—with its manageable safety profile—will be welcomed by the patient population.”

Relatlimab blocks lymphocyte-activation gene 3 (LAG-3), an immune checkpoint that is found on the surface of T cells. Nivolumab blocks programmed death-1 (PD-1), also an immune checkpoint found on the surface of T cells. Together, the complementary drugs restore function of T cells and promote an anti-tumor response.

Opdualag is the first FDA-approved LAG-3-blocking antibody combination.



ABOUT THE AIM AT MELANOMA FOUNDATION:  Melanoma is one of the fastest-growing cancers in the United States and worldwide.  It’s one of the most complex forms of cancer and has the most mutations of all solid cancers.  Founded in 2004, AIM at Melanoma is a global foundation dedicated to finding more effective treatments and, ultimately, the cure for melanoma while improving the lives of those it affects.  AIM’s global research initiatives include The International Melanoma Tissue Bank Consortium, The Melanoma International Collaboration for Adaptive Trials, and the International Melanoma Working Group.  AIM at Melanoma provides education, connection to resources and opportunities for meaningful engagement to help patients and caregivers/families better face the challenges of melanoma.  For more information, visit www.AIMatMelanoma.org and follow our groundbreaking initiatives on Facebook, Twitter, and YouTube.