FDA Accepts Supplemental Biologics License Application for Nivolumab in Melanoma

Nivolumab met its primary endpoint of recurrence-free survival, reducing the risk of recurrence or death by 58% versus placebo in patients with completely resected stage 2B or 2C melanoma.

The FDA has accepted a supplemental Biologics License Application from Bristol Myers Squibb for nivolumab (Opdivo) as an adjuvant treatment for patients with completely resected stage 2B or 2C melanoma. A Prescription Drug User Fee Act date has been set for October 13, 2023.1

Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to uniquely harness the body’s immune system to restore anti-tumor immune response. To date, the nivolumab clinical development program has treated more than 35,000 patients and it was the first PD-1 immune checkpoint inhibitor to receive regulatory approval globally in July 2014.1

The submission is based on safety and efficacy results from the pivotal phase 3 CheckMate -76K trial, in which nivolumab demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) versus placebo in patients with completely resected stage 2B or 2C melanoma. The safety profile was consistent with previously reported studies.1

“Melanoma can be a devastating diagnosis, and patients with stage 2B or 2C melanoma tend to be at high risk of disease recurrence,” said Gina Fusaro, PhD, vice president and development program lead at Bristol Myers Squibb, in a press release. “Approximately one-third of stage 2B and half of stage 2C patients experience recurrence within 5 years after surgery.”1

CheckMate -76K is a randomized, phase 3, double-blind study evaluating adjuvant nivolumab 480 mg every 4 weeks for up to 12 months versus placebo. The primary endpoint is RFS and secondary endpoints include overall survival, distant metastases-free survival, progression-free survival on next-line therapy, and safety endpoints.1

According to results from the CheckMate -76K trial presented in October 2022, nivolumab met its primary endpoint of RFS, reducing the risk of recurrence or death by 58% versus placebo. Twelve-month RFS rates for nivolumab were 89% versus 79% for placebo and this benefit was observed across predefined subgroups, including T category and disease stage.2

Twelve-month RFS rates by stage for patients who received nivolumab were 93% in stage 2B (versus 84% in placebo) and 84% in stage 2C (versus 72% with placebo).2

Grade 3 or 4 treatment-related adverse events (TRAEs) were 10% in the nivolumab arm and 2% in the placebo arm. TRAE-related discontinuation was 15% for those in the nivolumab arm and 3% for those in the placebo arm.2

The trial is part of a larger development program studying nivolumab and nivolumab-based combinations in earlier stages of cancer, currently spanning 7 tumor types. To date, nivolumab-based therapies have shown improved efficacy in the neoadjuvant or adjuvant treatment of non­–small cell lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer, and melanoma.1

Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells located in the skin. Metastatic melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin into other organs.

Approximately 97,610 new diagnoses of melanoma and 7990 related deaths are estimated for 2023 in the United States. The World Health Organization estimates that globally by 2035, melanoma incidence will reach 424,102, with 94,308 related deaths.1

The European Medicines Agency has also validated the Type II Variation Marketing Authorization Application for nivolumab as adjuvant monotherapy for this patient population.

“The data from the CheckMate -76K trial demonstrate the benefit that Opdivo can have for patients with this earlier stage of cancer,” Fusaro said in the press release. “We look forward to working with the US Food and Drug Administration and the European Medicines Agency to potentially offer a treatment option to patients with stage 2B or 2C melanoma that could help prevent recurrence.”1


  1. US Food and Drug Administration Accepts Bristol Myers Squibb’s Supplemental Biologics License Application and European Medicines Agency Validates Application for Opdivo (nivolumab). News release. Bristol Myers Squibb. February 28, 2023. Accessed February 28, 2023. https://news.bms.com/news/corporate-financial/2023/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Supplemental-Biologics-License-Application-and-European-Medicines-Agency-Validates-Application-for-Opdivo-nivolumab-/default.aspx
  2. Bristol Myers Squibb Presents Data from CheckMate -76K Showing Opdivo (nivolumab) Reduced the Risk of Recurrence or Death by 58% Versus Placebo in Patients with Completely Resected Stage IIB or IIC Melanoma. News release. Bristol Myers Squibb. October 19, 2022. Accessed February 28, 2023. https://news.bms.com/news/corporate-financial/2022/Bristol-Myers-Squibb-Presents-Data-from-CheckMate--76K-Showing-Opdivo-nivolumab-Reduced-the-Risk-of-Recurrence-or-Death-by-58-Versus-Placebo-in-Patients-with-Completely-Resected-Stage-IIB-or-IIC-Melanoma/default.aspx
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