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. He can be contacted at connect@pharmashots.com
