Pfizer: FDA approves immunotherapy for bladder cancer
(CercleFinance.com) - US health regulators have approved a drug developed by Merck KGaA and Pfizer that helps a patient's immune system to fight the most common type of advanced bladder cancer.
The FDA has approved the supplemental biologics license application (sBLA) for Bavencio for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with chemotherapy.
This approval is based on results from a Phase III study, which demonstrated that the treatment extended median overall survival by 50% relative to standard of care.
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