Therapy Detail
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| Therapy Name | Futibatinib |
| Synonyms | |
| Therapy Description |
Lytgobi (futibatinib) is a third-generation pan-FGFR inhibitor, which results in the inhibition of FGFR-mediated signal transduction pathways and tumor cell proliferation (PMID: 31109923). Lytgobi (futibatinib) is FDA approved for use in patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Futibatinib | Lytgobi | TAS-120 | FGFR Inhibitor (Pan) 26 | Lytgobi (futibatinib) is a third-generation pan-FGFR inhibitor, which results in the inhibition of FGFR-mediated signal transduction pathways and tumor cell proliferation (PMID: 31109923). Lytgobi (futibatinib) is FDA approved for use in patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FGFR2 rearrange | intrahepatic cholangiocarcinoma | sensitive | Futibatinib | FDA approved | Actionable | In a Phase II trial (FOENIX-CCA2) that supported FDA approval, Lytgobi (futibatinib) demonstrated safety and resulted in an objective response rate of 42% (43/103, 1 complete response, 42 partial responses), disease control rate of 83% (85/103), median duration of response of 9.7 mo, median progression-free survival of 9.0 mo, and median overall survival of 21.7 mo in patients with advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements (PMID: 36652354; NCT02052778). | detail... 36652354 |
| FGFR2 fusion FGFR2 K715R | intrahepatic cholangiocarcinoma | sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 K715R were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). | 31109923 |
| FGFR2 E718K | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 E718K were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 H544Q | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 H544Q were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR3 K650N | Advanced Solid Tumor | sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR3 K650N were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 Y375C | intrahepatic cholangiocarcinoma | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a clinical case study, Lytgobi (futibatinib) treatment resulted in a partial response with a progression-free survival of 35.5 months and a best objective response of -45% in a patient with intrahepatic cholangiocarcinoma harboring FGFR2 Y375C (reported as Y376C) (PMID: 39226398). | 39226398 |
| FGFR1 D128V | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 D128V were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 amp | breast cancer | sensitive | Futibatinib | Preclinical - Pdx | Actionable | In a preclinical study, Lytgoi (futibatinib) inhibited tumor growth and improved survival in a patient-derived xenograft (PDX) model of FGFR2-amplified breast cancer (PMID: 37980453). | 37980453 |
| FGFR2 amp | breast cancer | sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase I trial, Lytgobi (futibatinib) treatment resulted in a partial response in a patient with breast cancer harboring FGFR2 amplification, with 37% tumor shrinkage (Annals of Oncology (2020) 31 (suppl_4): S475). | detail... |
| FGFR2 P303L | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 P303L were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 N549S | Advanced Solid Tumor | sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 N549S were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 amp | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Phase I | Actionable | In a Phase I trial (FOENIX-101), Lytgobi (futibatinib) treatment demonstrated manageable safety profile, and resulted in a partial response in 6% (5/86) and stable disease in 48% (41/86) of patients with advanced solid tumors harboring FGF/FGFR aberrations, among whom 5% (4/74) harbored FGFR2 amplification (PMID: 32622884; NCT02052778). | 32622884 |
| FGFR2 Y375C | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 Y375C were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR1 A21T | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 A21T were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 N549H | Advanced Solid Tumor | sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 N549H were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 Y375C FGFR2 amp | triple-receptor negative breast cancer | sensitive | Futibatinib | Preclinical - Pdx | Actionable | In a preclinical study, Lytgobi (furibatinib) inhibited viability of cells derived from a patient-derived xenograft (PDX) model of FGFR2-amplified triple-negative breast cancer harboring FGFR2 Y375C in culture and induced tumor regression and improved survival in the patient-derived xenograft (PDX) model (PMID: 37980453). | 37980453 |
| FGFR2 fusion FGFR2 K660M | intrahepatic cholangiocarcinoma | sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 K660M were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). | 31109923 |
| FGFR1 S125L | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 S125L were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 E163K | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 E163K were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR1 S588T | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 S588T were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 fusion FGFR2 E566A | intrahepatic cholangiocarcinoma | sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 E566A were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). | 31109923 |
| FGFR2 R330W | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 R330W were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 H167_N173del FGFR2 L618F | intrahepatic cholangiocarcinoma | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase I trial, Lytgobi (futibatinib) treatment led to a partial response with 61% tumor reduction and response duration of 17 months in an intrahepatic cholangiocarcinoma patient harboring FGFR2 H167_N173del and FGFR2 L618F, which was consistent with inhibition of growth in an intrahepatic cholangiocarcinoma cell line expressing FGFR2 H167_N173del and FGFR2 L618F in culture (PMID: 33926920). | 33926920 |
| FGFR3 rearrange FGFR3 K650E | multiple myeloma | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment led to inhibition of cell proliferation in a multiple myeloma cell line harboring an FGFR3 rearrangement and FGFR3 K650E in culture (PMID: 32973082). | 32973082 |
| FGFR1 R809Q | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 R809Q were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 H242Y | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 H242Y were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 K310R FGFR2 N549K | endometrial adenocarcinoma | sensitive | Futibatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment led to tumor regression in a cell line xenograft model of endometrial adenocarcinoma harboring FGFR2 N549K and FGFR2 K310R (PMID: 37270847). | 37270847 |
| FGFR1 N546D | intrahepatic cholangiocarcinoma | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase I trial (FOENIX-101), Lytgobi (futibatinib) treatment resulted in a partial response in a patient with glioblastoma harboring FGFR1 N546D (PMID: 32622884; NCT02052778). | 32622884 |
| FGFR3 S249C PIK3CA E545K | bladder urothelial carcinoma | predicted - resistant | Futibatinib | Case Reports/Case Series | Actionable | In a clinical case study, a patient with bladder urothelial cancer harboring FGFR3 S249C and an acquired PIK3CA E545K experienced primary resistance to treatment with Lytgobi (futibatinib) (PMID: 37377403). | 37377403 |
| FGFR2 amp | stomach cancer | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase I trial, Lytgobi (futibatinib) treatment resulted in a partial response in 2 patients with gastric cancer harboring FGFR2 amplification, with 59% and 90% tumor shrinkage, respectively (Annals of Oncology (2020) 31 (suppl_4): S475). | detail... |
| FGFR2 amp | stomach cancer | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment inhibited growth of gastric cancer cells harboring FGFR2 amplification in culture (PMID: 33563752). | 33563752 |
| FGFR2 amp | stomach cancer | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase I trial, Lytgobi (futibatinib) treatment led to an overall objective response rate of 22% (2/9, 2 partial responses) and a disease control rate of 55.6% (5/9) in patients with gastric cancer harboring an FGFR2 amplification or FGFR3 rearrangement, including a progression-free survival of 4.8 months and a duration of response of 3.5 months in a patient with FGFR2 amplification (PMID: 34551969; NCT02052778). | 34551969 |
| FGFR2 amp | stomach cancer | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase I trial, Lytgobi (futibatinib) treatment resulted in clinical response in a gastric cancer patient harboring FGFR2 amplification (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 372PD). | detail... |
| FGFR2 E160K | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 E160K were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 K659N | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 K659N were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 E475K | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 E475K were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR1 amp | breast cancer | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment led to inhibition of cell proliferation in a breast cancer cell line harboring FGFR1 amplification in culture (PMID: 32973082). | 32973082 |
| FGFR2 C383R | intrahepatic cholangiocarcinoma | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase I trial, Lytgobi (futibatinib) treatment at a dose of 20mg led to an objective response rate of 15.6% (10/64) and a median progression-free survival of 5.1 months in patients with cholangiocarcinoma harboring FGF or FGFR 1-4 alterations, including a partial response with a progression-free survival of 9.2 months and a duration of response of 6.5 months in a patient with intrahepatic cholangiocarcinoma harboring FGFR2 C383R (PMID: 34551969; NCT02052778). | 34551969 |
| FGFR2 G364E | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 G364E were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 L33S | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 L33S were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 rearrange FGFR2 amp | cholangiocarcinoma | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase I trial, Lytgobi (futibatinib) treatment resulted in partial response in a patient with cholangiocarcinoma harboring FGFR2 rearrangement and FGFR2 amplification (Annals of Oncology, Volume 29, Issue suppl_5). | detail... |
| FGFR2 fusion | intrahepatic cholangiocarcinoma | sensitive | Futibatinib | FDA approved | Actionable | In a Phase II trial (FOENIX-CCA2) that supported FDA approval, Lytgobi (futibatinib) demonstrated safety and resulted in an objective response rate of 42% (43/103, 1 complete response, 42 partial responses), disease control rate of 83% (85/103), median duration of response of 9.7 mo, median progression-free survival of 9.0 mo, and median overall survival of 21.7 mo in patients with advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements (PMID: 36652354; NCT02052778). | detail... 36652354 |
| FGFR2 C382R FGFR2 N549D | intrahepatic cholangiocarcinoma | conflicting | Futibatinib | Case Reports/Case Series | Actionable | In a clinical case study, a patient with intrahepatic cholangiocarcinoma harboring FGFR2 C382R (reported as C383R) and FGFR2 N549D (reported as N550D) experienced progressive disease on treatment with Lytgobi (futibatinib), however, treatment in the patient-derived xenograft (PDX) model resulted in tumor growth inhibition (PMID: 39226398). | 39226398 |
| FGFR2 G305R | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 G305R were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 R6P | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 R6P were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 fusion FGFR2 H683L | intrahepatic cholangiocarcinoma | sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 H683L were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). | 31109923 |
| FGFR2 R664W | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 R664W were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR1 S238N | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 S238N were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 fusion FGFR2 L618V | intrahepatic cholangiocarcinoma | sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 L618V were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). | 31109923 |
| FGFR3 rearrange NRAS act mut | multiple myeloma | no benefit | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, a multiple myeloma cell line harboring an FGFR3 rearrangement and an NRAS activating mutation was not sensitive to treatment with Lytgobi (futibatinib) in culture (PMID: 32973082). | 32973082 |
| FGFR1 amp FGFR2 amp | breast cancer | sensitive | Futibatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment led to inhibition of cell proliferation in breast cancer cell lines harboring FGFR1 and FGFR2 amplification in culture, and led to inhibition of tumor growth in a cell line xenograft model (PMID: 32973082). | 32973082 |
| FGFR2 E596K | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 E596K were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 fusion FGFR2 V565F | intrahepatic cholangiocarcinoma | resistant | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 V565F were resistant to treatment, as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). | 31109923 |
| FGFR1 D320N | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 D320N were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 K310R | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 K310R were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR1 V751A | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 V751A were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 I422V | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 I422V were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 P253R | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 P253R were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 L560F | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 L560F were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR3 fusion | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Lytgobi (futibatinib) demonstrated growth inhibition and reduced FGFR phosphorylation in human cancer cell lines and xenograft models harboring FGFR mutations (Mol Cancer Ther 2013;12(11 Suppl):A270). | detail... |
| FGFR1 A121D | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 A121D were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR1 N546K | Advanced Solid Tumor | predicted - resistant | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 N546K were resistant to treatment with Lytgobi (futibatinib) in culture (PMID: 34272467). | 34272467 |
| FGFR1 M456V | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 M456V were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 R203H | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 R203H were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 K310R FGFR2 N549K | endometrial cancer | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment led to inhibition of cell proliferation in an endometrial cancer cell line harboring FGFR2 K310R and FGFR2 N549K in culture (PMID: 32973082). | 32973082 |
| FGFR2 H416R | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 H416R were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 V564F | Advanced Solid Tumor | predicted - resistant | Futibatinib | Preclinical - Biochemical | Actionable | In a preclinical study, Lytgobi (futibatinib) failed to inhibit Fgfr2 phosphorylation in cultured cells expressing FGFR2 V564F (PMID: 37270847). | 37270847 |
| FGFR1 over exp | stomach cancer | sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment inhibited growth of FGFR1-overexpressing gastric cancer cells in culture (PMID: 33563752). | 33563752 |
| FGFR1 amp | lung cancer | predicted - sensitive | Futibatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment led to inhibition of cell proliferation in lung cancer cell lines harboring FGFR1 amplification in culture, and led to inhibition of tumor growth in a cell line xenograft model with a daily dosing regimen, but not with an intermittent dosing regimen (PMID: 32973082). | 32973082 |
| FGFR1 R250W | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 R250W were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 N82K | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 N82K were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR3 S249C | transitional cell carcinoma | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase I trial, Lytgobi (futibatinib) treatment led to an overall objective response rate of 15.8% (3/19, 3 partial responses) and a disease control rate of 47.4% (9/19), with stable disease in 6, in urothelial cancer patients harboring an FGFR3 mutation or FGFR1 mutation, including partial responses in 2 patients with urothelial cancer harboring FGFR3 S249C with a progression-free survival of 2.7 and 4.7 mo, and a duration of response of 1.4 and 3.4 mo, respectively (PMID: 34551969; NCT02052778). | 34551969 |
| FGFR2 M186T | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 M186T were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 P253L | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 P253L were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 fusion FGFR2 N550K | intrahepatic cholangiocarcinoma | sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 N550K were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). | 31109923 |
| FGFR2 Y328N | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 Y328N were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR1 M563T | intrahepatic cholangiocarcinoma | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase I trial, Lytgobi (futibatinib) treatment led to an overall objective response rate of 15.8% (3/19, 3 partial responses) and a disease control rate of 47.4% (9/19), with stable disease in 6, in patients with urothelial cancer harboring an FGFR3 mutation or FGFR1 mutation, including a partial response with a progression-free survival of 6.8 mo and a duration of response of 5.6 mo in a urothelial cancer patient harboring FGFR1 M563T and amplifications in FGF3 and FGF19 (PMID: 34551969; NCT02052778). | 34551969 |
| FGFR2 fusion FGFR2 M538I | intrahepatic cholangiocarcinoma | sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 M538I were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). | 31109923 |
| FGFR3 rearrange FGFR3 F384L | multiple myeloma | no benefit | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, a multiple myeloma cell line harboring an FGFR3 rearrangement and FGFR3 F384L was not sensitive to treatment with Lytgobi (futibatinib) in culture (PMID: 32973082). | 32973082 |
| FGFR2 V392A | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 V392A were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR1 over exp | intrahepatic cholangiocarcinoma | no benefit | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, an intrahepatic cholangiocarcinoma cell line overexpressing FGFR1 was not sensitive to Lytgobi (futibatinib) in culture (PMID: 35420673). | 35420673 |
| FGFR1 K656E | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) inhibited growth of a cell line expressing FGFR1 K656E in culture (PMID: 34114373). | 34114373 |
| FGFR3 Y373C FGFR3 N540K FGFR3 V555L FGFR3 L608V | bladder urothelial carcinoma | predicted - resistant | Futibatinib | Case Reports/Case Series | Actionable | In a clinical case study, FGFR3 N540K, FGFR3 V555L, and FGFR3 L608V were identified in the post-progression circulating tumor DNA of a patient with bladder urothelial carcinoma harboring FGFR3 Y373C who previously responded to Lytgobi (futibatinib) treatment (PMID: 37377403). | 37377403 |
| FGFR1 V561F | Advanced Solid Tumor | predicted - resistant | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, treatment with Lytgobi (futibatinib) failed to inhibit cell growth and Fgfr1 downstream signaling in cells expressing FGFR1 V561F in culture (PMID: 34114373). | 34114373 |
| FGFR2 S252W | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 S252W were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR1 M563I FGFR1 K687E | oligodendroglioma | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase I trial (FOENIX-101), Lytgobi (futibatinib) treatment resulted in a partial response in a patient with anaplastic oligodendroglioma harboring FGFR1 M563I and FGFR1 K687E (PMID: 32622884; NCT02052778). | 32622884 |
| FGFR2 D101Y | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 D101Y were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 fusion | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Phase I | Actionable | In a Phase I trial (FOENIX-101), Lytgobi (futibatinib) treatment demonstrated manageable safety profile, and resulted in a partial response in 6% (5/86) and stable disease in 48% (41/86) of patients with advanced solid tumors harboring FGF/FGFR aberrations, among whom 20% (15/74) harbored FGFR2 fusions (PMID: 32622884; NCT02052778). | 32622884 |
| FGFR2 G613S | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 G613S were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR1 P483L | Advanced Solid Tumor | predicted - resistant | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 P483L were resistant to treatment with Lytgobi (futibatinib) in culture (PMID: 34272467). | 34272467 |
| FGFR1 K656N | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) inhibited growth of a cell line expressing FGFR1 K656N in culture (PMID: 34114373). | 34114373 |
| FGFR1 E467K | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 E467K were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR1 V561M | Advanced Solid Tumor | predicted - resistant | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, treatment with Lytgobi (futibatinib) failed to inhibit cell growth and Fgfr1 downstream signaling in cells expressing FGFR1 V561M in culture (PMID: 34114373). | 34114373 |
| FGFR3 rearrange FGFR3 Y373C | multiple myeloma | sensitive | Futibatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment led to inhibition of cell proliferation in a multiple myeloma cell line harboring an FGFR3 rearrangement and FGFR3 Y373C in culture, and led to tumor regression in a cell line xenograft model (PMID: 32973082). | 32973082 |
| FGFR2 R203C | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 R203C were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 K659E | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 K659E were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 fusion | biliary tract cancer | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase I trial, Lytgobi (futibatinib) treatment resulted in stable disease over 24 weeks in two biliary tract cancer patients harboring FGFR2 fusions (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 372PD). | detail... |
| FGFR2 C382R | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 C382R were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR1 T340M | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 T340M were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 amp | triple-receptor negative breast cancer | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase I trial, Lytgobi (futibatinib) treatment led to a partial response lasting 20.8 months and progression-free survival of 22.1 months in a triple-receptor negative breast cancer patient harboring an FGFR2 amplification (PMID: 34551969; NCT02052778). | 34551969 |
| FGFR1 S436F | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 S436F were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 G227E | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 G227E were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 A264T | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 A264T were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 P582L | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 P582L were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 N549K | endometrial cancer | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment led to inhibition of cell proliferation in an endometrial cancer cell line harboring FGFR2 N549K in culture (PMID: 32973082). | 32973082 |
| FGFR2 M640I | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 M640I were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 H167_N173del | intrahepatic cholangiocarcinoma | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) inhibited growth of an intrahepatic cholangiocarcinoma cell line expressing FGFR2 H167_N173del in culture (PMID: 33926920). | 33926920 |
| FGFR2 A67V | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 A67V were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 rearrange | cholangiocarcinoma | sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase I trial, Lytgobi (futibatinib) treatment resulted in partial response in 2 patients with cholangiocarcinoma harboring FGFR2 rearrangements (Annals of Oncology, Volume 29, Issue suppl_5). | detail... |
| FGFR2 rearrange | cholangiocarcinoma | sensitive | Futibatinib | Guideline | Actionable | Lytgobi (futibatinib) is included in guidelines as subsequent-line therapy (category 2A) for patients with cholangiocarcinoma harboring an FGFR2 fusion or rearrangement (NCCN.org). | detail... |
| FGFR2 Y375C | breast cancer | sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) inhibited Fgfr2 signaling and viability in breast epithelial cells expressing FGFR2 Y375C in culture (PMID: 37980453). | 37980453 |
| FGFR2 fusion FGFR2 N550H | intrahepatic cholangiocarcinoma | sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 N550H were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling (PMID: 31109923). | 31109923 |
| FGFR1 amp | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Phase I | Actionable | In a Phase I trial (FOENIX-101), Lytgobi (futibatinib) treatment demonstrated manageable safety profile, and resulted in a partial response in 6% (5/86) and stable disease in 48% (41/86) of patients with advanced solid tumors harboring FGF/FGFR aberrations, among whom 20% (15/74) harbored FGFR1 amplification (PMID: 32622884; NCT02052778). | 32622884 |
| FGFR2 A371V | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 A371V were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| BRAF L597Q FGFR2 H167_N173del FGFR2 L618F | intrahepatic cholangiocarcinoma | predicted - resistant | Futibatinib | Case Reports/Case Series | Actionable | In a clinical case study, acquisition of BRAF L597Q was identified in an intrahepatic cholangiocarcinoma patient harboring FGFR2 H167_N173del and FGFR2 L618F who developed resistance to treatment with Lytgobi (futibatinib) (PMID: 33926920). | 33926920 |
| FGFR2 R399Q | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 R399Q were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 S252W | endometrial cancer | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) treatment led to inhibition of cell proliferation in an endometrial cancer cell line harboring FGFR2 S252W in culture (PMID: 32973082). | 32973082 |
| FGFR2 R210Q | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 R210Q were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 W290C | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 W290C were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 Y375C | cholangiocarcinoma | sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) inhibited viability of a cholangiocyte cell line harboring FGFR2 Y375C in culture (PMID: 37980453). | 37980453 |
| FGFR2 C382R | intrahepatic cholangiocarcinoma | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a clinical case study, Lytgobi (futibatinib) treatment resulted in a partial response with a progression-free survival of 17.3 months and a best objective response of -53% in a patient with intrahepatic cholangiocarcinoma harboring FGFR2 C382R (reported as C383R) (PMID: 39226398). | 39226398 |
| FGFR2 S791T | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 S791T were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR1 T141R | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 T141R were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 W290C | intrahepatic cholangiocarcinoma | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase I trial, Lytgobi (futibatinib) treatment at a dose of 20mg led to an objective response rate of 15.6% (10/64) and a median progression-free survival of 5.1 months in patients with cholangiocarcinoma harboring FGF or FGFR 1-4 alterations, including a partial response with a progression-free survival of 12.7 months and a duration of response of 9.9 months in an intrahepatic cholantiocarcinoma patient harboring FGFR2 W290C (PMID: 34551969; NCT02052778). | 34551969 |
| FGFR2 C62Y | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 C62Y were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 Q212K | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 Q212K were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 A389T | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 A389T were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 N549D | Advanced Solid Tumor | sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 N549D were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR1 D133N | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 D133N were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 fusion | cholangiocarcinoma | sensitive | Futibatinib | Guideline | Actionable | Lytgobi (futibatinib) is included in guidelines as second or later-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions (PMID: 36372281; ESMO.org). | 36372281 detail... |
| FGFR2 fusion | cholangiocarcinoma | sensitive | Futibatinib | Phase I | Actionable | In a Phase I trial, Lytgobi (futibatinib) treatment resulted in an objective response rate of 25% (7/28, 7 partial responses) in patients with cholangiocarcinoma harboring FGFR2 fusions, with 71% of patients experienced tumor shrinkage, 54% (15/28) achieved stable disease (Annals of Oncology, Volume 29, Issue suppl_5). | detail... |
| FGFR2 fusion | cholangiocarcinoma | sensitive | Futibatinib | Guideline | Actionable | Lytgobi (futibatinib) is included in guidelines as subsequent-line therapy (category 2A) for patients with cholangiocarcinoma harboring an FGFR2 fusion or rearrangement (NCCN.org). | detail... |
| FGFR1 R475Q | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 R475Q were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR3 S249C FGFR3 N540K | intrahepatic cholangiocarcinoma | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lytgobi (futibatinib) inhibited viability of a bladder cancer cell line harboring FGFR3 S249C and expressing FGFR3 N540K in culture (PMID: 38437671). | 38437671 |
| FGFR1 T26I | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR1 T26I were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
| FGFR2 R251Q | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing FGFR2 R251Q were sensitive to treatment with Lytgobi (futibatinib) in culture, demonstrating reduced cell viability (PMID: 34272467). | 34272467 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05727176 | Phase II | Futibatinib | Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement (FOENIX-CCA4) | Recruiting | USA | POL | ITA | ESP | BRA | AUS | ARG | 5 |
| NCT05615818 | Phase III | Niraparib ZW25 Binimetinib + Encorafenib Futibatinib Cisplatin + Gemcitabine Neratinib + Trastuzumab Ivosidenib | Personalized Medicine for Advanced Biliary Cancer Patients (SAFIR-ABC10) | Recruiting | GBR | FRA | BEL | 0 |
| NCT04507503 | Expanded access | Futibatinib | Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements | Approved for marketing | USA | 0 |
| NCT04024436 | Phase II | Fulvestrant + Futibatinib Futibatinib | A Study of TAS-120 in Patients With Metastatic Breast Cancer | Active, not recruiting | USA | ITA | GBR | FRA | ESP | CAN | 1 |
| NCT04189445 | Phase II | Futibatinib | Futibatinib in Patients With Specific FGFR Aberrations | Active, not recruiting | USA | TUR | SWE | NLD | ITA | GBR | FRA | ESP | DEU | BEL | 5 |
| NCT03784014 | Phase III | Ceritinib Dabrafenib + Trametinib Capmatinib Durvalumab + Olaparib Nilotinib Futibatinib Trametinib Palbociclib Glasdegib Lapatinib | Molecular Profiling of Advanced Soft-tissue Sarcomas (MULTISARC) | Active, not recruiting | FRA | 0 |
| NCT03767075 | Phase II | Amivantamab-vmjw Futibatinib Atezolizumab | A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets) (BoB) | Recruiting | SWE | NLD | ITA | GBR | FRA | ESP | DEU | 0 |
| NCT02052778 | Phase Ib/II | Futibatinib | A Study of TAS-120 in Patients With Advanced Solid Tumors | Completed | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 4 |
| NCT04093362 | Phase III | Futibatinib Cisplatin + Gemcitabine | Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements (FOENIX-CCA3) | Terminated | USA | POL | NLD | ITA | GBR | FRA | ESP | DEU | BRA | BEL | AUS | ARG | 8 |
CKB BOOST