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New Drug:  Futibatinib for cholangiocarcinoma

New Drug:  Futibatinib for cholangiocarcinoma
Study:
  • A single-arm, multicenter, phase 2 study
  • Advanced/metastatic unresectable iCCA harboring FGFR2 gene fusions
  • Disease progression after ≥1 line of systemic therapy
  • Futibatinib 20 mg QD until disease progression/unacceptable toxicity ( n=103)
Efficacy:
  • ORR: 42 % [32.0-52.0]
  • mDoR: 9.7 mos [7.6-17.1 mos]
Safety:
  • Any grade AEs: hyperphosphatemia (79.1%), diarrhea (37.3%), dry mouth (32.8%)
  • Grade ≥3 AEs: hyperphosphatemia (25.4%)
  • Treatment related death: 2 patients

Goyal L, Meric-Bernstam F

Goyal L, Meric-Bernstam F et al. A phase II, open-label, multicenter study of futibatinib in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions or other rearrangements.

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-futibatinib-cholangiocarcinoma?utm_medium=email&utm_source=govdelivery

Reviewed by Elvin CHALABİYEV, MD on Jan 30, 2023

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