![]() Results from the primary analysis of CheckMate -274 were presented in an oral presentation during the American Society of Clinical Oncology Genitourinary Cancers Symposium in February 2021. ![]() Opdivo was generally well tolerated, with a safety profile that was consistent with previously reported Opdivo studies in patients with solid tumors. placebo, regardless of patients’ PD-L1 expression levels. In the trial, Opdivo demonstrated a statistically significant and clinically meaningful increase in disease-free survival (DFS) vs. The filing was based on results from the pivotal CheckMate -274 trial, the first positive Phase 3 trial of an immunotherapy in this setting. We look forward to working with the FDA towards the goal of bringing the first adjuvant immunotherapy option to these patients in the U.S.” ![]() “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. “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,” said Dana Walker, M.D., M.S.C.E., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 3, 2021. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma, based on results from the CheckMate -274 trial. PRINCETON, N.J.-(BUSINESS WIRE)- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration assigned a target action date of Septemif approved, Opdivo would be the first adjuvant immunotherapy option for patients with muscle-invasive urothelial carcinoma in the U.S.ĬheckMate -274 is one of four positive Phase 3 trials for Opdivo -based treatments in earlier stages of cancers Application based on Phase 3 CheckMate -274 trial, in which Opdivo nearly doubled disease-free survival compared to placebo
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