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FDA approves BMS’s Opdualag for metastatic or unresectable melanoma

The new, first-in-class fixed-dose dual immunotherapy combination treatment is administered as a single intravenous infusion


Bristol Myers Squibb (BMS) has announced that Opdualag (nivolumab and relatlimab-rmbw) has received approval from the US Food and Drug Administration (FDA) for the treatment of adult and paediatric patients aged 12 years or older with metastatic melanoma or melanoma which cannot be treated with surgery.

Opdualag is a new, first-in-class, fixed-dose, dual immunotherapy combination treatment and is administered as a single intravenous infusion.

Melanoma is a type of skin cancer, presenting as an uncontrolled growth of pigment-producing cells (melanocytes) found in the skin. Metastatic melanoma is noted as being the deadliest form of the disease, occurring when cancer spreads beyond the surface of the skin to other organs.

Over the last 30 years, melanoma has been increasing steadily, and in the US, around 99,780 new diagnoses of melanoma and around 7,650 related deaths are estimated for 2022. Although it can be mostly treatable if caught in its very early stages, survival rates of melanoma can decrease as the condition continues to progress.

The FDA based its approval on the phase 2/3 RELATIVITY-047 trial – a global, randomised, double-blind study – which compared Opdualag to nivolumab alone. During the trial, Opdualag more than doubled median progression-free survival, compared to nivolumab monotherapy – an established standard of care.

“The availability of this treatment combination may enable patients to potentially benefit from a new, first-in-class dual immunotherapy,” said Michael Kaplan, president and CEO, Melanoma Research Alliance.

Samit Hirawat, chief medical officer, global drug development at BMS, said: “The approval of a new medicine that includes our third distinct checkpoint inhibitor marks an important step forward in giving patients more options beyond monotherapy treatment.”

Article by
Fleur Jeffries

23rd March 2022

From: Regulatory



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