Bristol Myers Squibb has announced that the FDA has accepted their supplemental Biologics License Application (sBLA), and the European Medicines Agency (EMA) has validated their Type II Variation Marketing Authorization Application (MAA) for Opdivo® (nivolumab) as monotherapy in the adjuvant setting for treating patients with completely resected stage IIB or IIC melanoma. The FDA has given a Prescription Drug User Fee Act (PDUFA) date of October 13, 2023, while the EMA's validation of the application confirms the submission is complete and starts the EMA's centralized review process.
According to Gina Fusaro, PhD, Vice President of Development Program Lead at Bristol Myers Squibb, patients with stage IIB or IIC melanoma are at high risk of disease recurrence, and the CheckMate -76K trial's data shows how Opdivo can benefit these patients. 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. The safety profile of Opdivo was consistent with previously reported studies. The study's results were presented as late-breaking data during a plenary session at the Society for Melanoma Research (SMR) Annual Meeting in October 2022.
Bristol Myers Squibb's development program is studying Opdivo and Opdivo-based combinations in earlier stages of cancer, which currently spans seven tumor types. To date, Opdivo-based therapies have shown improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types: non-small cell lung cancer (NSCLC), bladder cancer, esophageal/gastroesophageal junction cancer, and melanoma. The company thanks the patients and investigators involved in the CheckMate -76K trial.
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