FDA approval for first in class immunotherapy for advanced melanoma

pharmafile | March 21, 2022 | News story | Sales and Marketing  

The FDA has approved Bristol-Myers Squibb’s Opdualag (nivolumab and relatlimab-rmbw), the first drug in a new class of cancer immunotherapies, as an initial treatment for advanced melanoma in patients aged 12 and older.

The drug has been approved for the treatment of unresectable or, the deadliest form of skin cancer.

“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,” said F Stephen Hodi, MD, director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute. “Today’s approval is particularly significant, as it introduces an entirely new combination of two immunotherapies that may act together to help improve anti-tumor response by targeting two different immune checkpoints – LAG-3 and PD-1.”

This application was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.

“While we have made great progress in the treatment of advanced melanoma over the past decade, we are committed to expanding dual immunotherapy treatment options for these patients,” Samit Hirawat, chief medical officer, global drug development at BMS said in a statement. “Inhibiting LAG-3 with relatlimab, in a fixed-dose combination with nivolumab, represents a new treatment approach that builds on our legacy of bringing innovative immunotherapy options to patients.”

Melanoma is a form of cancer usually beginning in the skin. In advanced melanoma, the cells have spread from the primary site – where the cancer first started – to other parts of the body. Melanoma cells can travel through the blood or lymphatic system, which helps protect us from infection and disease. Advanced melanoma is also known as stage 4 melanoma, or metastatic melanoma.

Ana Ovey

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