The FDA on Friday withdrew an accelerated approval for Helsinn’s bile duct cancer drug, two years after the company couldn’t complete its confirmatory trial and requested that the FDA withdraw approval.
In May 2021, regulators granted accelerated approval to infigratinib, marketed as Truseltiq, to treat certain forms of cholangiocarcinoma, which is a cancer affecting the bile duct. But Helsinn pulled its new drug application in 2022 and removed it from the market in the US and Europe after it had trouble getting and keeping people enrolled in confirmatory trials.
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