USFDA accepts Bristol Myers Squibb's Application for Opdivo
The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 13, 2022.;
Princeton- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus chemotherapy for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (NSCLC), based on results from the CheckMate -816 trial. The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 13, 2022.
"While significant progress has been made in how we treat non-small cell lung cancer, there remains a strong need for new options that can prevent recurrence and improve clinical outcomes, especially when a patient's cancer is caught in earlier stages," said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. "The FDA's acceptance of our application marks an important step in our effort to offer patients and physicians the first immunotherapy-based option that can be given before surgery to extend the time patients can continue living without disease progression or recurrence. We look forward to working with the FDA to potentially bring this regimen to patients in the U.S., where lung cancer is the leading cause of cancer deaths."
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