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FDA Sets Action Date for Opdivo for Melanoma Indication


BMS is seeking an indication for Opdivo as monotherapy to treat patients with stage IIB or IIC melanoma after surgery. The FDA has assigned a Prescription Drug User Fee Act date of Oct. 13, 2023.

The FDA has accepted the supplemental biologics license application (sBLA) for Opdivo (nivolumab) as monotherapy to treat patients with stage IIB or IIC melanoma after surgery. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of Oct. 13, 2023.

Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells located in the skin. In the United States, about 97,610 new diagnoses of melanoma and about 7,990 related deaths are estimated for 2023. Melanomas can be mostly treatable when caught in very early stages; however, survival rates can decrease as the disease progresses.

Developed by Bristol Myers Squibb, Opdivo is PD-1 immune checkpoint inhibitor that is designed to harness the body’s own immune system to help restore anti-tumor immune response. It is already indicated for patients 12 years of age or older with melanoma with involvement of lymph nodes or metastatic disease. Opdivo-based therapies are also approved for other tumors, including non-small cell lung cancer (NSCLC), bladder cancer and esophageal/gastroesophageal junction cancer.

Georgina Long, M.D., Ph.D,

Georgina Long, M.D., Ph.D,

“Within five years after surgery, one third of stage IIB and one half of IIC patients see their cancer return. Helping reduce that risk remains a need to be addressed when it comes to treating melanoma,” Professor Georgina Long, M.D., Ph.D., co-medical director of Melanoma Institute Australia (MIA) and chair of melanoma medical oncology and translational research at MIA, The University of Sydney, and Royal North Shore and Mater Hospitals, said in a press release.

The submission was based on safety and efficacy results from the pivotal phase 3 CheckMate -76K trial, in which Opdivo demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) versus placebo in patients with completely resected stage IIB or IIC melanoma. Twelve-month RFS rates for Opdivo were 89% versus 79% for placebo. Opdivo reduced the risk of recurrence or death by 58% versus placebo.

No new safety signals were observed at the time of the analysis. Grade 3/4 treatment-related adverse events (TRAEs) were 10% in the Opdivo arm and 2% in the placebo arm. Treatment-related adverse events -related discontinuation was 15% for those in the Opdivo arm and 3% for those in the placebo arm.

Results from CheckMate -76K were presented during a plenary session at the Society for Melanoma Research (SMR) Annual Meeting in October 2022.

At the same time, the European Medicines Agency (EMA) has validated the Type II Variation Marketing Authorization Application (MAA), which confirms the submission is complete and begins the start of the EMA’s centralized review process.

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