The company filed its sBLA application based on the Phase 3 CheckMate -274 trial, in which Opdivo increased disease-free survival
Bristol Myers Squibb has received the US Food and Drug Administration (FDA) priority review for Opdivo (nivolumab) to treat a type of urothelial carcinoma.
The drug is indicated as an adjuvant treatment for patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.
FDA has accepted the company’s supplemental Biologics License Application (sBLA) for Opdivo and assigned a Prescription Drug User Fee Act (PDUFA) goal date of 3 September 2021.
Bristol Myers Squibb vice president and genitourinary cancers development programme lead Dana Walker said: “After patients undergo surgery for muscle-invasive urothelial carcinoma, they continue to face uncertainties given the high rate of disease recurrence and the lack of safe and effective treatment options.
“Based on the ground-breaking disease-free survival results from CheckMate -274, we believe Opdivo has the potential to change the future of treatment for muscle-invasive urothelial carcinoma.
“We look forward to working with the FDA towards the goal of bringing the first adjuvant immunotherapy option to these patients in the US.”
The FDA priority review is based on results from the CheckMate -274 trial, a randomised, double-blind, multi-centre study evaluating Opdivo compared to placebo.
In the trial, Opdivo has shown a statistically significant and clinically meaningful increase in disease-free survival (DFS) compared to placebo, said the company.
The drug was generally well-tolerated, with a consistent safety profile with previously conducted studies in patients with solid tumours.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that enables the body’s own immune system to help restore anti-tumour immune response.
CheckMate -274 is part of a series of four Phase 3 trials in earlier stages of cancers, including muscle-invasive urothelial carcinoma, melanoma, esophageal/gastroesophageal junction cancer and non-small cell lung cancer.
In June last year, the company has secured FDA approval for Opdivo to treat a type of esophageal squamous cell carcinoma (ESCC).