Bristol Myers Squibb announced that the FDA has accepted the supplemental Biologics License Application (BLA) for Opdivo (nivolumab) as monotherapy in the adjuvant setting for the treatment of patients with completely resected stage IIB or IIC melanoma. The company also announced that the European Medicines Agency (EMA) has validated the Type II Variation Marketing Authorization Application (MAA) for Opdivo.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 13, 2023. In Europe, the EMA’s validation of the application confirms the submission is complete and begins the start of the EMA’s centralized review process.

The submissions were 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, according to a company news release. The safety profile of Opdivo was consistent with previously reported studies.

“Melanoma can be a devastating diagnosis, and patients with stage IIB or IIC melanoma tend to be at high risk of disease recurrence. Approximately one third of stage IIB and half of stage IIC patients experience recurrence within 5 years after surgery,” Gina Fusaro, PhD, vice president, development program lead, Bristol Myers Squibb, said in a company news release. “The data from the CheckMate -76K trial demonstrate the benefit that Opdivo can have for patients with this earlier stage of cancer. We look forward to working with the U.S. Food and Drug Administration and the European Medicines Agency to potentially offer a treatment option to patients with stage IIB or IIC melanoma that could help prevent recurrence.”

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