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FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements.

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Affiliations

  • 1. Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
      Authors
    • Gandhy SU 1
    • Casak SJ 1
    • Kufrin D 1
    • Thompson MD 1
    • Jarrell K 1
    • Auth D 1
    • Lemery SJ 1
    • Pazdur R 1
    • Kluetz PG 1
    • Fashoyin-Aje LA 1
    (10 authors)
  • 2. Office of Biostatistics, Office of Translational Sciences (OTS), CDER, U.S. FDA, Silver Spring, Maryland.
      Authors
    • Mushti SL 2
    • Cheng J 2
    (2 authors)
  • 3. Office of Clinical Pharmacology, OTS, CDER, U.S. FDA, Silver Spring, Maryland.
      Authors
    • Subramaniam S 3
    • Zhao H 3
    • Zhao M 3
    • Bi Y 3
    • Liu G 3
    • Fan J 3
    • Adeniyi O 3
    • Charlab R 3
    (8 authors)

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Clinical Cancer Research : an Official Journal of the American Association for Cancer Research, 01 Oct 2023, 29(20):4027-4031
https://doi.org/10.1158/1078-0432.ccr-23-1042 PMID: 37289037 

Abstract 

On September 30, 2022, the FDA granted accelerated approval to futibatinib for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions or other rearrangements. Approval was based on Study TAS-120-101, a multicenter open-label, single-arm trial. Patients received futibatinib 20-mg orally once daily. The major efficacy outcome measures were overall response rate (ORR) and duration of response (DoR) as determined by an independent review committee (IRC) according to RECIST v1.1. ORR was 42% (95% confidence interval, 32%-52%). Median DoR was 9.7 months. Adverse reactions occurring in ≥30% patients were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, and abdominal pain. The most common laboratory abnormalities (≥50%) were increased phosphate, increased creatinine, decreased hemoglobin, and increased glucose. Ocular toxicity (including dry eye, keratitis, and retinal epithelial detachment) and hyperphosphatemia are important risks of futibatinib, which are listed under Warnings and Precautions. This article summarizes the FDA's thought process and data supporting the approval of futibatinib.

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Read article at publisher's site: https://doi.org/10.1158/1078-0432.ccr-23-1042

Read article for free, from open access legal sources, via Unpaywall: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10592512Unpaywall

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