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.
Infigratinib was on a winding road to approval from the get-go.
BridgeBio in-licensed the drug from Novartis back in 2018 and put up $65 million to QED Therapeutics to run studies. In 2021, BridgeBio cut a $2.4 billion deal with Helsinn to bring infigratinib over the finish line, but Helsinn later withdrew from its agreement with BridgeBio, citing “commercial considerations.”
Truseltiq’s accelerated approval was part of the FDA’s Real-Time Oncology Review program, which provides an expedited review timeline for key oncology drugs. The approval was also a part of the agency’s Project Orbis, which allows for concurrent review of drugs across international regulatory agencies.
Helsinn did not return Endpoints News’ request for comment.