BMS Receives the CHMP’s Positive Opinion for Opdivo (Nivolumab) as a 1L Treatment of Urothelial Carcinoma
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The CHMP has granted positive opinion to Opdivo + CT (cisplatin & gemcitabine) as 1L treatment of metastatic or unresectable urothelial carcinoma adults (n=608). The decision is anticipated in Jun 2024
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The opinion was based on a sub-study of the P-III (CheckMate–901), assessing Opdivo (360mg, Q3W, 6 cycles) + CT (cisplatin & gemcitabine) followed by Opdivo (480mg, Q4W) vs SoC CT alone to treat urothelial cancer (n=608)
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The study showed improved OS & PFS. The combination reduced the death risk by 22% with a mOS of 21.7mos. vs 18.9mos. (CT alone) at a median follow-up of 33mos. and reduced the risk of disease progression or death by 28%, with a mPFS of 7.9mos. vs 7.6mos. (CT alone)
Ref: BMS | Image: BMS
Related Post:- BMS Reports the Updated Data from P-III (CheckMate -73L) Study of Opdivo for Non-Small Cell Lung Cancer
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
