FDA approves Opdivo (nivolumab) with chemotherapy for first-line treatment of advanced bladder cancer.
The FDA has approved Bristol Myers Squibb's Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma, the most common form of bladder cancer. The approval is based on the Phase 3 CheckMate-901 trial, which demonstrated a 22% reduction in the risk of death and a median overall survival of 21.7 months for patients receiving Opdivo and chemotherapy, compared to 18.9 months for those receiving chemotherapy alone. This marks a significant advancement in treating metastatic or unresectable urothelial carcinoma.
March 07, 2024
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