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Taiho Oncology Announces Publication in The New England Journal of Medicine of Pivotal Data for Futibatinib in Previously Treated Patients With Metastatic Intrahepatic Cholangiocarcinoma

  • Treatment with futibatinib resulted in durable responses and survival surpassing historical data with chemotherapy in patients with previously treated disease.
  • Patients in the study reported stable quality of life over nine months of treatment.
  • Data supported U.S. Food and Drug Administration accelerated approval of LYTGOBI® (futibatinib) tablets in September 2022; continued approval may be contingent upon a confirmatory trial(s).

Excerpt from the Press Release:

PRINCETON, N.J., January 18, 2023 – Taiho Oncology, Inc. today announced the publication of results from the pivotal Phase 2 FOENIX*-CCA2 clinical trial of futibatinib in the January 19, 2023 issue of The New England Journal of Medicine (NEJM). The article, “Futibatinib for Intrahepatic Cholangiocarcinoma with FGFR2 Fusions/Rearrangements,” reports on data from the FOENIX-CCA2 trial, a global open-label study evaluating patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

These data supported the U.S. Food and Drug Administration (FDA) accelerated approval of futibatinib tablets – brand name LYTGOBI® – in September 2022 for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic iCCA harboring FGFR2 gene fusions or other rearrangements. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1

In the FOENIX-CCA2 trial, futibatinib showed clinically meaningful benefit in previously treated patients with FGFR2 fusion/rearrangement-positive iCCA, including an objective response rate of 42%, as assessed by independent review, and a median response duration of 9.7 months. Treatment with futibatinib resulted in durable responses and survival that surpassed historical data with chemotherapy in patients with previously treated iCCA.

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