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FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements
Open accessAbstract
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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Several pan-FGFR inhibitors, such as futibatinib and infigratinib, are approved for treating FGFR-altered cancers.
“Several pan-FGFR inhibitors, such as futibatinib and infigratinib, are approved for treating FGFR-altered cancers.60,61”
From Paneth-like transition drives resistance to dual targeting of KRAS and EGFR in colorectal cancer (2026) · cites this paper as [60]
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New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
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Jain, A., Borad, M. J., Kelley, R. K., Wáng, Y., Abdel‐Wahab, R., Meric‐Bernstam, F., Baggerly, K., Kaseb, A. O., Al-Shamsi, H. O., Ahn, D. H., et al. (2018) · JCO Precision Oncology · doi:10.1200/po.17.00080 · Cited by 174
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Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies
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Self-citationGoyal, L., Meric‐Bernstam, F., Hollebecque, A., et al. (2022) · Journal of Clinical Oncology · doi:10.1200/jco.2022.40.16_suppl.4009 · Cited by 54
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- U.S. Food and Drug Administration, NDA Multi-disciplinary Review and Evaluation (NDA 214665) LYTGOBI (futibatinib)
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Paneth-like transition drives resistance to dual targeting of KRAS and EGFR in colorectal cancer
Zhang, Y., Chen, J., She, Y., Fang, Z., Zhang, Y., Ruan, D., Guo, W., Liao, J., Zhou, W., Lao, J., et al. (2026) · Cancer Cell · doi:10.1016/j.ccell.2025.10.010 · Cited by 23
“60,61 Additionally, isoform-selective FGFR3 inhibitors (e.g., LOXO-435) are under clinical investigation.”
Metadata
- Authors
- Gandhy, S. U., Casak, S. J., Mushti, S. L., Cheng, J., Subramaniam, S., Zhao, H., Zhao, M., Bi, Y., Liu, G., Fan, J., Adeniyi, O., Charlab, R., Kufrin, D., Thompson, M. D., Jarrell, K., Auth, D., Lemery, S. J., Pazdur, R., Kluetz, P. G., & Fashoyin-Aje, L. A.
- Affiliations
- United States Food and Drug Administration (US)
- 3Office of Clinical Pharmacology, OTS, CDER, U.S. FDA, Silver Spring, Maryland.
- 1Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
- Corresponding author
- Gandhy, Shruti U.
- ORCID
- Gandhy, Shruti U.
- Casak, Sandra J.
- Mushti, Sirisha L.
- Cheng, Joyce
- Subramaniam, Sriram
- Zhao, Hong
- Zhao, Miao
- Bi, Youwei
- Liu, Guansheng
- Fan, Jianghong
- Adeniyi, Oluseyi
- Charlab, Rosane
- Kufrin, Dubravka
- Thompson, Matthew D.
- Jarrell, Kristin
- Auth, Doris
- Lemery, Steven J.
- Pazdur, Richard
- Kluetz, Paul G.
- Fashoyin-Aje, Lola A.
- Venue
- Clinical Cancer Research
- Published
- 2023-06-08
- Volume
- 29
- Issue
- 20
- Pages
- 4027-4031
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- PMC
- PMC10592512
- OpenAlex
- W4379768380
- Semantic Scholar
- befb7e2c5419eafb88b41c457a29f07fd53daa10
- Cited by
- 25
- References
- 10
- Citations by year
- 2026: 9 · 2025: 8 · 2024: 7 · 2023: 1
- FWCI
- 6.70
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Clinical Cancer Research (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- U.S. Food and Drug Administration
- Topics
- Health Sciences › Medicine › Surgery › Cholangiocarcinoma and Gallbladder Cancer Studies
- Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Keywords
- futibatinib, intrahepatic cholangiocarcinoma, FGFR2 fusion, FGFR2 rearrangement, accelerated approval, FDA drug approval, tyrosine kinase inhibitors, ocular toxicity, hyperphosphatemia, adverse drug reactions
- MeSH terms
- Adult, Bile Duct Neoplasms, Bile Ducts, Intrahepatic, Humans, Pyrazoles, Pyrimidines, Pyrroles, Drug Approval, Cholangiocarcinoma, Receptor, Fibroblast Growth Factor, Type 2
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