FDA grants priority review to Opdivo for non-small cell lung cancer indication
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The FDA granted priority review to nivolumab for use with chemotherapy as neoadjuvant treatment of patients with resectable non-small cell lung cancer.
Nivolumab (Opdivo, Bristol Myers Squibb), a PD-1 immune checkpoint inhibitor, is approved in the United States for several oncology indications. These apply to use of the agent by specific patients with NSCLC, melanoma, mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, gastric cancer, esophageal squamous cell carcinoma and gastroesophageal junction cancer.
The FDA based the new priority review designation on results of the randomized phase 3 CheckMate -816 trial, which enrolled patients with resectable NSCLC regardless of PD-L1 expression.
The primary analysis included 358 patients randomly assigned to neoadjuvant platinum doublet chemotherapy with or without nivolumab, followed by surgery. Pathologic complete response and EFS served as the primary endpoints. Secondary endpoints included OS, major pathologic response, and time to death or metastases.
Results showed the nivolumab-chemotherapy combination significantly improved EFS and pathologic complete response. The combination exhibited a safety profile consistent with that observed in prior studies in NSCLC.
“[Although] 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,” Abderrahim Oukessou, MD, vice president and thoracic cancers development lead with Bristol Myers Squibb, said in a company-issued press release. “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.”
The FDA is expected to make a decision on approval by July 13. If approved, the nivolumab-chemotherapy combination would be the first neoadjuvant immunotherapy-based option for patients with resectable NSCLC in the United States.
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