Helsinn to Withdraw NDA for Cholangiocarcinoma

Helsinn Healthcare has decided to withdraw its New Drug Application (NDA) of Truseltiq (infigratinib) and permanently discontinue U.S. distribution of the drug, which had been granted accelerated FDA approval for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

Helsinn and BridgeBio had inked a collaboration and licensing agreement for infigratinib in March 2021. An updated deal in March gave Helsinn an exclusive license to commercialize infigratinib in the U.S.

Helsinn announced that it will stop supplying Truseltiq capsules as of March 31, 2023; the company provided no reason for the discontinuation.

As a result of Helsinn’s withdrawal of Truseltiq, BridgeBio also will close an ongoing phase 3 clinical trial for use of the drug in treating first-line cholangiocarcinoma.