Bristol Myers announces to regulatory acceptances for Opdivo

Bristol Myers Squibb announced two regulatory acceptances for applications for neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer. The FDA accepted the supplemental Biologics Application, or sBLA, and assigned a Prescription Drug User Fee Act, or PDUFA, goal date of October 8. In late January, the European Medicines Agency, or EMA, validated the type II variation application which confirms the submission is complete and begins the start of the EMA’s centralized review process. “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, as part of our comprehensive approach to the treatment of multiple types of cancer, including and especially in earlier stages,” said Abderrahim Oukessou, vice president, thoracic cancers global program lead, Bristol Myers Squibb. The submissions were based on results from the Phase 3 CheckMate -77T trial, which represents the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of resectable NSCLC, showing statistically significant and clinically meaningful improvements in event-free survival, the study’s primary endpoint. The study also showed benefits in key secondary endpoints including pathologic complete response and major pathologic response. Additionally, the perioperative regimen had a safety profile consistent with previously reported studies in NSCLC and no new safety signals were identified.