FDA has accepted the supplemental Biologics License Application 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.
FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act goal date of September 3, 2021.
The filing was based on results from the pivotal CheckMate -274 trial, the first positive phase III trial of an immunotherapy in this setting. In the trial, Opdivo demonstrated a statistically significant and clinically meaningful increase in disease-free survival vs. placebo, regardless of patients’ PD-L1 expression levels.
Opdivo was generally well-tolerated, with a safety profile that was consistent with previously reported Opdivo studies in patients with solid tumors. 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.
CheckMate -274 is one of four positive phase III trials for Opdivo-based treatments in earlier stages of cancers, including muscle-invasive urothelial carcinoma (CheckMate -274), melanoma (CheckMate -238), esophageal/gastroesophageal junction cancer (CheckMate -577) and non-small cell lung cancer (CheckMate -816).
