FDA grants accelerated approval to futibatinib for cholangiocarcinoma

FDA

30 September 2022 - Today, the Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi, Taiho) for adult patients with previously treated, unresectable, locally advanced or metastatic intra-hepatic cholangiocarcinoma harbouring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

Efficacy was evaluated in TAS-120-101, a multi-centre, open-label, single-arm trial that enrolled 103 patients with previously treated, unresectable, locally advanced, or metastatic intra-hepatic cholangiocarcinoma harbouring a FGFR2 gene fusion or other rearrangement.

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Michael Wonder

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Michael Wonder