FDA withdraws Helsinn’s accelerated approval for cancer drug after company’s request

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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