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FDA Approves Opdivo for First Line Treatment in Bladder Cancer

Phase 3 trial demonstrates statistically significant improvement in overall survival and progression-free survival compared to cisplatin-gemcitabine alone.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Bristol Myers Squibb received approval from the U.S. FDA Opdivo (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer. This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy, compared to cisplatin-gemcitabine alone, for patients wit...

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