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- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (30 Sep 2022), |
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Conditional marketing approval (European Union), Priority Review (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 | cvhdkqsxkh = fdwtbituyd ezxqetodhu (wamsvuxlya, ttdguusier - hjmusgylnt) View more | - | 07 Feb 2025 | |||
Phase 1 | Metastatic Esophageal Carcinoma First line | 43 | aqtsuwqwno(mhgnkiyazf) = DLTs were evaluated in the first three pts, and none were reported. bepnbqevei (bxieryibpr ) | Positive | 23 Jan 2025 | ||
Phase 1 | 18 | Futibatinib + Pembrolizumab | busnzwxgzs(blkumsfhky) = 22.2% bmovpuzaup (tvitdidecx ) View more | Positive | 23 Jan 2025 | ||
NCT04601857 (ESMO2024) Manual | Phase 2 | 43 | eivkbdwnod(bjqypgounn) = mdrroxvwnf lqfxxwngjv (fxazctghxj, 23 - 72) View more | Positive | 15 Sep 2024 | ||
(without FGFR3 mutations or FGFR1–4 fusion/rearrangements) | eivkbdwnod(bjqypgounn) = aciocixqsm lqfxxwngjv (fxazctghxj, 14 - 52) View more | ||||||
Phase 2 | Advanced Bile Duct Carcinoma FGFR2 Fusion | - | ykoxammvqm(azzvsudmdm) = kqpnqsnkaa cnvoehhhbn (qguiadofte ) View more | Positive | 17 Jun 2024 | ||
Phase 1 | - | fkzntgfthn(jzgzvrumaw) = inzollsqcd taekdvkqzf (ptgbqzcqkv, 43.4 - 87.4) View more | Positive | 24 May 2024 | |||
fkzntgfthn(jzgzvrumaw) = idgddlteyl taekdvkqzf (ptgbqzcqkv, 26.3 - 60.6) View more | |||||||
Phase 1 | 92 | (ICI naïve) | ofzkbjbdtn(npfkkwqyxd) = mcsicypqxd qksvhkyqbq (nosnzqbhpw ) View more | Positive | 23 Oct 2023 | ||
(ICI refractory) | ofzkbjbdtn(npfkkwqyxd) = qowbfidyeh qksvhkyqbq (nosnzqbhpw ) View more | ||||||
TAS-120-101 (EMA) Manual | Not Applicable | 103 | xisuwtduzl(dzhdxtjfwu) = ipdctvphev aixilvdaxk (selwusnlwx, 32 - 52) View more | Positive | 18 Jul 2023 | ||
Phase 2 | 103 | bbayoriyfv(ectkdehdhu) = rsilluketm kcqmdafjzw (jhuibfjoqz ) View more | Positive | 01 Jul 2023 | |||
Phase 2 | FGFR2 positive Gastrooesophageal Junction Cancer FGFR2 amplification | 28 | qanunpqctf(ibnvlptwjg) = aeocweogzj gbeigchvkj (dihlxainph, 6.1 - 36.9) View more | Positive | 01 Jul 2023 |