Bristol Myers Squibb Submits Regulatory Applications for Opdivo as Adjuvant Therapy for IIB/IIC Stage Melanoma in the US and EU

On February 28, Bristol-Myers Squibb (BMS) announced that the FDA has accepted the supplemental Biologics License Application (sBLA) for the PD-1 inhibitor nivolumab (Opdivo) as a monotherapy adjuvant treatment for patients with Stage IIB or IIC melanoma, and the European Medicines Agency (EMA) has validated the corresponding marketing application. In the United States, the PDUFA date is October 13, 2023. In Europe, the EMA's validation of the application confirms the completeness of the submission and indicates the start of EMA's centralized review process.

These applications are based on the efficacy and safety results of the pivotal Phase III CheckMate -76K study. Compared with placebo, nivolumab provided a statistically significant and clinically meaningful improvement in relapse-free survival (RFS) for patients with completely resected stage IIB or IIC melanoma.

CheckMate -76K is part of BMS's development program studying nivolumab and its combinations in early-stage cancer (adjuvant, neoadjuvant, and perioperative settings), covering seven tumor types. To date, nivolumab-based therapies have demonstrated superior efficacy in the neoadjuvant or adjuvant treatment of four tumor types, including non-small cell lung cancer (NSCLC), bladder cancer, esophageal/gastroesophageal junction cancer, and melanoma.

"Melanoma can be a devastating disease, and patients with Stage IIB or IIC melanoma often face a high risk of recurrence. Approximately one-third of patients with Stage IIB and half of those with Stage IIC will experience a recurrence within five years after surgery," said Dr. Gina Fusaro, Vice President and Head of Development at Bristol-Myers Squibb. "The data from the CheckMate -76K study demonstrate the benefit of nivolumab for patients with this early-stage cancer. We look forward to working with the FDA and EMA to potentially offer a treatment option that may help prevent recurrence in patients with Stage IIB or IIC melanoma."

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