FDA & EMA Accept Opdivo Filings for Resectable NSCLC

Bristol Myers Squibb has launched two clinical trials for neoadjuvant Opdivo (nivolumab) and adjuvant Opdivo and postoperative chemotherapy for the treatment of unresectable stages IIA to IIIB small resectable breast cancer (NSCLC). The United States agreed. Food and Drug Administration (FDA) to the Supplemental Biologics Application (sBLA) and presented the Prescription Drug User Fee Act (PDUFA) on October 8, 2024. The European Medicines Agency (EMA) will approve the type in late January. This Variant II application confirms that your submission is complete and initiates the start of the EMA and 039 number review process.

Between 30% and 55% of patients with non-small cell lung cancer undergo surgery, and the disease comes back. "We are committed to expanding options to improve outcomes for patients with dementia as part of our comprehensive approach to treating a variety of cancers, particularly early-stage cancer," said the Global Vice President of Thoracic Cancers. Dr. Abderrahim Oukessou: program Leader, Bristol Myers Squibb.

“With CheckMate -77T, we have evaluated the potential for neoadjuvant immunotherapy to induce pathological complete response and the role of perioperative Opdivo treatment in reducing the likelihood that the cancer will return and help make extended survival possible for patients. The acceptance of these applications underscores our impactful progress in addressing unmet needs across several non-small cell lung cancer treatment settings and brings us one step closer to offering a new perioperative Opdivo-based regimen to patients who may benefit.

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 (EFS), the study’s primary endpoint.