Bristol Myers Squibb (BMS) has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy. This is intended as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. The FDA has set a target action date of April 5, 2024.
The application is based on the results of the Phase 3 CheckMate -901 trial, which demonstrated a statistically significant and clinically meaningful survival benefit of the Opdivo-based regimen over the standard-of-care gemcitabine plus cisplatin treatment in this patient population. The trial’s data showcased improvements in both overall survival (OS) and progression-free survival (PFS), while maintaining a tolerable safety profile with no new concerns.
If approved, this combination would mark the first immunotherapy-chemotherapy regimen authorized for these patients in the U.S., providing a potential new treatment option for a condition with few efficacious first-line therapies. Bristol Myers Squibb (BMS) acknowledges the patients and investigators who contributed to the CheckMate -901 trial and foresees working closely with the FDA during the review process. Opdivo-based combinations have made noteworthy strides in improving overall survival in various tumors, signifying a pivotal advancement for individuals battling metastatic urothelial carcinoma.
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