FDA withdraws accelerated approval for Truseltiq in cholangiocarcinoma

The US Food and Drug Administration (FDA) announced the final withdrawal of the approval of BridgeBio Pharma (Nasdaq: BBIO) Truseltiq (infigratinib) for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

The news sent BridgeBio’s shares down more than 3% to $30.09 on Friday.

The accelerated approval of infigratinib required the sponsor to conduct post-marketing trials to verify the clinical benefit of the drug, said the FDA, adding that the sponsor voluntarily requested withdrawal of infigratinib.