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."
The filing was based on results from the pivotal CheckMate -816 study, the first positive Phase 3 trial with an immunotherapy-based combination in the neoadjuvant setting of NSCLC. In the trial, Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) and event-free survival (EFS) versus chemotherapy alone when given before surgery. The safety profile of Opdivo plus chemotherapy was consistent with previously reported studies in NSCLC. Results from CheckMate -816 were presented at the 2021 American Association for Cancer Research (pCR data) and the 2021 American Society of Clinical Oncology (surgical outcomes) annual meetings. Bristol Myers Squibb is working with investigators to present the CheckMate -816 EFS results at an upcoming medical conference.
To date, Opdivo-based therapies have shown improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma. In non-metastatic NSCLC specifically, the company and collaborators are exploring the use of immunotherapy in the neoadjuvant, adjuvant and peri-operative settings, as well as in association with chemoradiation. Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -816 clinical trial.
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