Bistol Myers Squibb (BMY) announced that the U.S. Food and Drug Administration has accepted for priority review its supplemental Biologics License Application or sBLA for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.
The application has been accepted based on results from the Phase 3 CheckMate -901 trial. The results showed significant survival improvement vs. standard-of-care gemcitabine plus cisplatin in cisplatin-eligible patients with untreated, unresectable or metastatic urothelial carcinoma.
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 5, 2024.
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the U.S., the company noted.
Dana Walker, vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb, said, "The FDA's acceptance of our application for Opdivo in combination with cisplatin-based chemotherapy represents important progress toward addressing the unmet need for options that may offer durable responses and improved survival for patients with metastatic urothelial carcinoma. There remains a clear need for efficacious first-line treatment options that may potentially help improve outcomes for patients with this hard-to-treat disease."
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