The U.S. Food and Drug Administration on Thursday approved UroGen Pharma's drug to treat a type of bladder cancer.
The approval comes despite its panel of external advisors last month narrowly voting against backing the drug as the members criticized the single-arm trial for the drug.
The FDA cited the drug's late-stage trial data on 223 patients, in which 78% showed a complete response to the drug.
The drug, branded Zusduri, will be the first to get approval to treat a type of bladder cancer that has not spread beyond the inner layers of the organ, and which primarily affects older populations.
U.S.-listed shares of the Israel-based company were halted for trading.