Bristol Myers Opdivo Label Expansion Under FDA and EU Review

Bristol Myers Squibb (NYSE:BMY) revealed on Wednesday that it has secured the attention of the U.S. and EU drug regulators for extending the existing indications of its anti-PD-1 therapy Opdivo in the realm of lung cancer.

The company has submitted a supplemental biologics application (sBLA) to the FDA and a type II variation application to the European Medicines Agency (EMA) to expand the usage of Opdivo as an adjuvant therapy in non-small cell lung cancer (NSCLC) post-surgery.

While Opdivo is already sanctioned for various tumors, including as a neoadjuvant therapy in non-small cell lung cancer, Bristol Myers now aims to gain approval for its perioperative utilization in resectable stage IIA to IIIB non-small cell lung cancer following neoadjuvant Opdivo and chemotherapy.

“Between 30% to 55% of non-small cell lung cancer patients who undergo surgery will experience disease recurrence. We are working to expand options that improve outcomes for patients with resectable disease,” said Abderrahim Oukessou, BMY’s global lead for the thoracic cancer program.

The FDA has accepted BMY’s SBLA, setting October 8, 2024, as the target action date. Both applications were based on the company’s Phase 3 CheckMate-77T trial, indicating a statistically significant enhancement for the main goal of event-free survival.