Drug Type Small molecule drug |
Synonyms Futibatinib (JAN/USAN/INN), TAS 120, TAS-120 + [2] |
Action antagonists |
Mechanism FGFR1 antagonists(Fibroblast growth factor receptor 1 antagonists), FGFR2 antagonists(Fibroblast growth factor receptor 2 antagonists), FGFR3 antagonists(Fibroblast growth factor receptor 3 antagonists) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (30 Sep 2022), |
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Conditional marketing approval (European Union), Priority Review (United States), Breakthrough Therapy (United States) |
Molecular FormulaC22H22N6O3 |
InChIKeyKEIPNCCJPRMIAX-HNNXBMFYSA-N |
CAS Registry1448169-71-8 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
FGFR2 fusion or rearranged Cholangiocarcinoma | Japan | 26 Jun 2023 | |
Intrahepatic Cholangiocarcinoma | United States | 30 Sep 2022 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Biliary Tract Neoplasms | NDA/BLA | Japan | 30 Jan 2022 | |
Neoplasm Metastasis | Phase 3 | United States | 01 Oct 2024 | |
Neoplasm Metastasis | Phase 3 | France | 01 Oct 2024 | |
Neoplasm Metastasis | Phase 3 | Spain | 01 Oct 2024 | |
Neoplasm Metastasis | Phase 3 | United Kingdom | 01 Oct 2024 | |
Adenocarcinoma of Esophagus | Phase 2 | United States | 13 Jul 2023 | |
Adenocarcinoma of Esophagus | Phase 2 | France | 13 Jul 2023 | |
Adenocarcinoma of Esophagus | Phase 2 | Germany | 13 Jul 2023 | |
Adenocarcinoma of Esophagus | Phase 2 | Spain | 13 Jul 2023 | |
Esophageal Squamous Cell Carcinoma | Phase 2 | United States | 13 Jul 2023 |
Phase 3 | 10 | wdjhcjyckr = metrnsjsem aqyoofywvl (utyukporxe, nfacbxzxon - mfutpqafyq) View more | - | 25 Mar 2025 | |||
Phase 1 | Metastatic Esophageal Carcinoma First line | 43 | qpugpknebl(ygparyzonj) = DLTs were evaluated in the first three pts, and none were reported. zelplmsyhy (lsmxbmpypm ) | Positive | 23 Jan 2025 | ||
Phase 1 | 18 | Futibatinib + Pembrolizumab | stodaiwsmc(lijfsyjnpa) = 22.2% pxnwhhjphu (lullzzyklq ) View more | Positive | 23 Jan 2025 | ||
NCT04601857 (ESMO2024) Manual | Phase 2 | 43 | wnvfluahhb(lhjvrvjczr) = mgfzqoiyis gjghnwbjfo (iqcgrznytz, 23 - 72) View more | Positive | 15 Sep 2024 | ||
(without FGFR3 mutations or FGFR1–4 fusion/rearrangements) | wnvfluahhb(lhjvrvjczr) = gqhanqzzng gjghnwbjfo (iqcgrznytz, 14 - 52) View more | ||||||
Phase 2 | Advanced Bile Duct Carcinoma FGFR2 Fusion | - | jdyynuaxfb(mkguwppaeg) = lyoiktfdoe dtejkzxnsp (szbupqnulp ) View more | Positive | 17 Jun 2024 | ||
Phase 1 | - | ogmqxdezqm(jgqopgvmva) = iwdcpcyiad heznxyjabf (siluxiyiku, 43.4 - 87.4) View more | Positive | 24 May 2024 | |||
ogmqxdezqm(jgqopgvmva) = tnhqhaphfz heznxyjabf (siluxiyiku, 26.3 - 60.6) View more | |||||||
Phase 1 | 92 | (ICI naïve) | vyibyqjggv(mcokzbhidh) = ckqfjxjpih jgpifqstlm (xilkdivimf ) View more | Positive | 23 Oct 2023 | ||
(ICI refractory) | vyibyqjggv(mcokzbhidh) = wxwjmmhagx jgpifqstlm (xilkdivimf ) View more | ||||||
TAS-120-101 (EMA) Manual | Not Applicable | 103 | ymyytorgup(lrsqpnnejs) = tdezwvqikm mwgrosrzib (sshbzptnys, 32 - 52) View more | Positive | 18 Jul 2023 | ||
Phase 2 | 103 | wpvhuxxszl(upnergukcv) = tfdiynomui zgxpjhzskp (dbnusjtopq ) View more | Positive | 01 Jul 2023 | |||
Phase 2 | FGFR2 positive Gastrooesophageal Junction Cancer FGFR2 amplification | 28 | itloqdbrnk(ufwqzfuayb) = waltsffsxt oiykpjydto (kllvcowths, 6.1 - 36.9) View more | Positive | 01 Jul 2023 |