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.
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