Bristol Myers Squibb Opdivo in combo with cisplatin based chemotherapy gets EMA validation for Urothelial Carcinoma

Princeton: Bristol Myers Squibb has announced that the European Medicines Agency (EMA) has validated its type II variation application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, based on results from the Phase 3 CheckMate -901 trial. Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.
“We know that approximately 20% to 25% of patients diagnosed with urothelial carcinoma will experience disease metastasis, and an additional 5% of patients present de novo with metastatic disease. As a result, first-line treatment options that may offer these patients a chance for durable responses and improved survival outcomes are needed,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, genitourinary cancers, Bristol Myers Squibb. “We are pleased that the CheckMate -901 trial has displayed potential for Opdivo in combination with cisplatin-based chemotherapy to help address this unmet need and provide hope for patients and their loved ones. We are eager to continue working with the European Medicines Agency to discuss how we may bring this first-line regimen to appropriate patients across Europe.”
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