CHMP recommends Opdivo for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma – BMS
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression greater than 1% who are at a high risk of recurrence after undergoing radical resection. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.
The positive opinion is based on results from the Phase III CheckMate -274 study, which demonstrated a statistically significant and clinically meaningful increase in disease-free survival (DFS) with Opdivo compared to placebo in both all randomized patients and in patients whose tumor cells express PD-L1 greater than 1%. Opdivo is the first and only immunotherapy to significantly improve the median time patients lived without disease recurrence in a randomized, placebo-controlled clinical trial in this setting. Opdivo was generally well tolerated, with a safety profile that was consistent with previously reported Opdivo studies in patients with solid tumors. Results from CheckMate -274 were first presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium in February 2021 and published in the New England Journal of Medicine in June 2021.