Urogen Pharma's (URGN) Zusduri treatment was approved by the US Food and Drug Administration for the treatment of adult patients with a type of bladder cancer, the agency said Thursday.
The regulator said the medicine was approved as a treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
Last month, the FDA's Oncologic Drugs Advisory Committee narrowly voted against the medicine's approval.
The FDA's decision was based on a single-arm, multicenter trial in 240 adults. Of the 223 patients evaluable for response, 78% had a complete response, a measure of how well a cancer drug works, the FDA said.
Shares were halted earlier and have yet to resume trading.
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