Drugs / Futibatinib
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed cholangiocarcinoma 1 milestone | |||||
| Filed | US (FDA) | — | cholangiocarcinoma | 2022-03-30 | “the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for futibatinib” taihooncology.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved · conditional | EU (EMA) | Lytgobi | — | 2023-07-04 | europa.eu ↗ |
| Approved | US (FDA) | LYTGOBI | — | 2022-09-30 | fda.gov ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials · 1 missed | ||||||
| Phase 1 | NCT07594548 | Sep 2027 → Sep 2030 expected | esophageal adenocarcinoma, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Northwestern University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05827614 | Mar 2023 → Mar 2026 | cervical squamous cell carcinoma, endometrial carcinoma, estrogen-receptor positive breast cancer, head and neck squamous cell carcinoma +7 | Boundless Bio, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT04965818 | Sep 2021 → Jun 2023 | non-small cell lung carcinoma | Taiho Oncology, Inc. | Terminated | Missed primary Stop: Business |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT02813135 | Aug 2016 → Feb 2031 expected | childhood malignant neoplasm | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02052778 | Jul 2014 → Oct 2020 | breast cancer, cholangiocarcinoma, gastric cancer, primary brain neoplasm +1 | Taiho Oncology, Inc. | Completed | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT07639528 | Dec 2027 → Dec 2030 expected | intrahepatic cholangiocarcinoma | Northwestern University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06722183 | Dec 2025 → Mar 2028 expected | colorectal cancer | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting | No outcome recorded |
| Phase 2 | NCT06263153 | Dec 2024 → Jul 2027 expected | infiltrating bladder urothelial carcinoma | Yuanquan Yang | Recruiting | No outcome recorded |
| Phase 2 | NCT05945823 | Jul 2023 → Oct 2026 expected | esophageal adenocarcinoma, esophageal squamous cell carcinoma, gastroesophageal cancer, malignant pancreatic neoplasm | Taiho Oncology, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05727176 | Jul 2023 → Dec 2026 expected | cholangiocarcinoma | Taiho Oncology, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT05036681 | Sep 2021 → Sep 2024 | endometrial carcinoma, metastatic malignant neoplasm | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT04828486 | Aug 2021 → Sep 2024 | hepatocellular carcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT04601857 | Jan 2021 → Mar 2024 | urothelial carcinoma | Taiho Oncology, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04189445 | Aug 2020 → Nov 2024 | gastroesophageal cancer, hematopoietic and lymphoid cell neoplasm | Taiho Oncology, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04024436 | Jan 2020 → May 2023 | breast cancer | Taiho Oncology, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03767075 | Dec 2018 → May 2025 overdue | neoplasm | Vall d'Hebron Institute of Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT02693535 | Mar 2016 → Dec 2027 expected | non-Hodgkin lymphoma, plasma cell myeloma | American Society of Clinical Oncology | Recruiting | Mixed |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06506955 | Oct 2024 → Apr 2027 expected | metastatic neoplasm | Taiho Oncology, Inc. | Enrolling by invitation | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07710885 | Jun 2026 → Apr 2030 expected | biliary tract cancer | Taiho Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05615818 | Jul 2024 → Jun 2027 expected | biliary tract neoplasm | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT04093362 | Jan 2021 → Apr 2024 | cholangiocarcinoma | Taiho Oncology, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03784014 | Oct 2019 → Dec 2023 | soft tissue sarcoma | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04507503 | — | cholangiocarcinoma | Taiho Oncology, Inc. | Approved for marketing | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT04999761 Background | Jun 2021 → May 2026 overdue | alveolar soft part sarcoma, biliary tract cancer, colorectal cancer, esophageal cancer +4 | Taiho Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-05-23 | Boundless Bio, Inc. | Results Boundless Bio Announces Portfolio Prioritization and Runway Extension boundlessbio.com ↗
In addition, the combinations of BBI-355 with the EGFR inhibitor erlotinib, and with the FGFR inhibitor futibatinib, were not well-tolerated with Q2D dosing at the exposure levels believed to be required for robust, sustained anti-tumor activity. |
| 2023-01-18 | Taiho Oncology, Inc. | Results Taiho Oncology Announces Publication in The New England Journal of Medicine of Pivotal Data for Futibatinib in Previously Treated Patients With Metastatic Intrahepatic Cholangiocarcinoma taihooncology.com ↗
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. |
| 2022-09-30 | Taiho Oncology, Inc. | Regulatory FDA Approves Taiho’s LYTGOBI® (futibatinib) Tablets for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma taihooncology.com ↗
This indication is approved under accelerated approval based on overall response rate and duration of response. |
| 2022-06-03 | Taiho Oncology, Inc. | Results Taiho Oncology Announces Updated Efficacy and Safety Data for Futibatinib in Cholangiocarcinoma at 2022 ASCO Annual Meeting taihooncology.com ↗
Taiho Oncology, Inc. announced today updated results of the Phase 2 FOENIX-CCA2 trial of futibatinib, confirming results observed in an earlier analysis. |
| 2022-03-30 | Taiho Oncology, Inc. | Regulatory U.S. Food and Drug Administration (FDA) Accepts for Priority Review Taiho Oncology’s New Drug Application for Futibatinib for Cholangiocarcinoma taihooncology.com ↗ |
| 2021-04-11 | Taiho Oncology, Inc. | Results Taiho Oncology Announces Presentation of Phase 2 Data for Futibatinib (TAS-120) in Advanced Intrahepatic Cholangiocarcinoma at Virtual AACR Annual Meeting 2021 taihooncology.com ↗
The study met its primary endpoint of a greater than 20% objective response rate (ORR) assessed by independent central review with an ORR of 41.7%. |
| 2021-04-01 | Taiho Oncology, Inc. | Regulatory FDA Grants Breakthrough Therapy Designation for Taiho Oncology’s Futibatinib for Treatment of Advanced Cholangiocarcinoma taihooncology.com ↗
“We are very pleased with the designation of futibatinib as a breakthrough therapy by the FDA,” said Teruhiro Utsugi, Ph.D., Senior Managing Director at Taiho. |
| 2020-06-04 | Taiho Oncology, Inc. | Results Taiho Oncology To Present Data on Futibatinib (TAS-120) at the AACR Annual Meeting 2020 taihooncology.com ↗
Futibatinib (TAS-120) plus chemotherapy demonstrated a synergistic effect across various FGFR-deregulated cancer cell lines and xenograft models (Abstract 564). |
| 2020-05-31 | Taiho Oncology, Inc. | Results Taiho Oncology Announces Presentation of Data for Futibatinib in Advanced Intrahepatic Cholangiocarcinoma at 2020 ASCO Meeting taihooncology.com ↗
The interim analysis reported data for 67 patients (65%) with a minimum of 6 months of follow up and found the ORR was 37.3% (1 CR=1.5%; 24 PR=35.8%). |
| 2018-06-20 | Taiho Oncology, Inc. | Results Taiho Oncology Presents Data on Key Investigational Compound TAS-120 at ESMO 20th World Congress on Gastrointestinal Cancer 2018 taihooncology.com ↗
This is a presentation of updated clinical data for TAS-120 in cholangiocarcinoma, a rare cancer with limited treatment options. |
| 2018-06-14 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier to Present Data on LONSURF® (trifluridine and tipiracil) and Key Investigational Compound TAS-120 at ESMO 20th World Congress on Gastrointestinal Cancer 2018 taihooncology.com ↗
A pivotal Phase III trial (TAGS) evaluating LONSURF® plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic gastric cancer refractory to standard therapies met its primary endpoint of prolonged overall survival (OS) (Abstract LBA-002). |
All press releases naming this drug 17 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Futibatinib | “An Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements” NCT04507503 ↗ |
| Known as | Fgfr-in-1 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3701238 ↗ |
| Known as | Lytgobi | ChEMBL registry synonym — accepted as the source's own label CHEMBL3701238 ↗ |
| Known as | TAS-120 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04507503 ↗ |
| Action | Inhibit | “Futibatinib is an oral, irreversible, highly selective fibroblast growth factor receptor (FGFR)1-4 inhibitor with potent preclinical activity against tumors harboring FGFR aberrations.” PMID 32622884 ↗ Jul 2020 |
| Modality | Small molecule | — CHEMBL3701238 ↗ |
| Route | Oral | “The patients received oral futibatinib at a dose of 20 mg once daily in a continuous regimen.” PMID 36652354 ↗ Jan 2023 |
| Target | FGFR1 | “Futibatinib, a next-generation, covalently binding FGFR1-4 inhibitor, has been shown to have both antitumor activity in patients with FGFR-altered tumors and strong preclinical...” PMID 36652354 ↗ Jan 2023 |