FDA Accepts Bristol Myers Squibb’s sBLA for Nivolumab for Resected Stage IIB/C Melanoma

deepstock/AdobeStock

The US Food and Drug Administration (FDA) has recently accepted Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) as monotherapy adjuvant therapy for the treatment of completely resected stage IIB or IIC melanoma. The European Medicine Agency (EMA) has also validated the Type II Variation Marketing Authorization Application (MAA) for nivolumab. In the US, the FDA has given Bristol Myers Squibb a Prescription Drug User Fee Act (PDUFA) date of October 13, 2023.

The sBLA is based on safety and efficacy data of the pivotal phase 3 trial, CheckMate – 76K. In the clinical trial, nivolumab, a programmed death-1 (PD-1) immune checkpoint inhibitor, demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival compared to placebo in patients with completely resected stage IIb or IIC melanoma. Additionally, the safety profile of nivolumab was similar to previous studies. Positive results from the CheckMate –76K trial were presented at the Society for Melanoma Research Annual Meeting in October 2022 at a late-breaking plenary session.

The primary end point of CheckMate – 76K is recurrence-free survival. Key secondary endpoints of the trial include overall survival, distant metastases-free survival, progression-free survival on next-line therapy, and safety endpoints. According to Bristol Myers Squibb, no new safety signals were observed at the time of the analysis.CheckMate – 76K is a randomized, phase 3, double-blind study investigating 480mg of adjuvant nivolumab dosed every 4 weeks for up to 12 months compared to placebo.

Gina Fusaro, PhD, vice president and development program lead at Bristol Myers Squibb noted that melanoma is a devastating diagnosis with an unfortunately high risk of disease recurrence for patients with stage IIB or IIC melanoma. Fusaro hopes the FDA and EMA acceptances will help bring treatment options to patients with IIB or IIC melanoma.

In Europe, the EMA’s validation of the MMA for nivolumab initiates the start of the centralized review process.

Reference

1. US Food and Drug Administration accepts Bristol Myers Squibb’s supplemental biologics license application and European Medicines Agency validates application for Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma. Bristol Myers Squibb. Published 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