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    3ms
    A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene Positivity Who Progressed After Chemotherapy (clinicaltrials.gov)
    P=N/A, N=60, Recruiting, Eisai Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
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    Tasfygo (tasurgratinib)
    4ms
    Sequential Fibroblast Growth Factor Receptor Inhibition in Intrahepatic Cholangiocarcinoma: Navigating an Evolving Landscape of Resistance and Opportunity-A Case Report and Current Opinion. (PubMed, Oncol Ther)
    Here, we report a case of FGFR2-rearranged iCCA where the patient achieved a radiographic partial response (PR) to tasurgratinib (a third-line FGFR inhibitor) following prior progression on pemigatinib and futibatinib. More broadly, this report serves as a basis for a current opinion on the evolving landscape of sequential FGFR inhibition in iCCA. We delve into the complexities of acquired resistance, dissect the arguments for and against prolonged FGFR pathway blockade, explore the impact of co-occurring genomic alterations, discuss the controversies, research priorities, and the urgent need for a balanced perspective to guide future clinical practice and trial design in this rapidly advancing but still uncertain field.
    Journal
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    FGFR2 (Fibroblast growth factor receptor 2) • FGFR (Fibroblast Growth Factor Receptor)
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    FGFR2 rearrangement
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    Lytgobi (futibatinib) • Pemazyre (pemigatinib) • Tasfygo (tasurgratinib)
    4ms
    Tasurgratinib (E7090) for cholangiocarcinoma with fibroblast growth factor receptor 2 fusions/rearrangements: a multicenter, open-label, Phase 2 study. (PubMed, Jpn J Clin Oncol)
    The primary endpoint (ORR) met the study's predefined success criteria. Tasurgratinib had a manageable safety profile consistent with previous reports and the known pharmacological profile of FGFR inhibitors.
    P2 data • Journal
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    FGFR2 (Fibroblast growth factor receptor 2)
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    FGFR2 fusion • FGFR fusion
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    gemcitabine • Tasfygo (tasurgratinib)
    5ms
    NCCH2006/MK010 Trial (FORTUNE Trial) (clinicaltrials.gov)
    P2, N=75, Recruiting, National Cancer Center, Japan | Active, not recruiting --> Recruiting | N=46 --> 75 | Trial completion date: Dec 2024 --> Mar 2028 | Trial primary completion date: Dec 2024 --> Mar 2028
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • FGFR2 (Fibroblast growth factor receptor 2) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • FGFR4 (Fibroblast growth factor receptor 4) • NTRK (Neurotrophic receptor tyrosine kinase)
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    EGFR mutation • BRAF mutation • NRAS mutation • BRAF V600 • FGFR2 mutation • FGFR2 fusion • FGFR mutation
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    Tasfygo (tasurgratinib)
    5ms
    First Successful Treatment of Advanced Intrahepatic Cholangiocarcinoma with Tasurgratinib Following Regulatory Approval: A Case Report from Clinical Practice. (PubMed, Int J Mol Sci)
    We report the case of a 55-year-old female with advanced iCCA harboring an FGFR2-BICC1 fusion, who experienced a rapid clinical response to tasurgratinib following disease progression on gemcitabine, cisplatin, and durvalumab (GCD). This is the first report to describe the real-world clinical efficacy of tasurgratinib in an iCCA patient with FGFR2-BICC1 fusion. Our findings suggest that tasurgratinib can provide a rapid and durable response with manageable toxicity in molecularly selected patients who have progressed on standard therapies.
    Journal • PD(L)-1 Biomarker
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    FGFR2 (Fibroblast growth factor receptor 2) • BICC1 (BicC Family RNA Binding Protein 1)
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    FGFR2 fusion
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    cisplatin • Imfinzi (durvalumab) • gemcitabine • Tasfygo (tasurgratinib)
    8ms
    Effect of Tasurgratinib as an Orally Available FGFR1-3 Inhibitor on Resistance to a CDK4/6 Inhibitor and Endocrine Therapy in ER+/HER2- Breast Cancer Preclinical Models. (PubMed, Cancers (Basel))
    FGF signaling plays a role in resistance to CDK4/6 inhibitors and ET in ER+ BC. Tasurgratinib has the potential to exhibit significant antitumor activity in combination with ET against ER+ BC via FGF signaling inhibition. These findings indicate the therapeutic potential of tasurgratinib in treating ER+ BC.
    Preclinical • Journal
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • FGFR1 (Fibroblast growth factor receptor 1) • FGF2 (Fibroblast Growth Factor 2) • FGF10 (Fibroblast Growth Factor 10)
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    HER-2 negative • ESR1 mutation
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    Ibrance (palbociclib) • fulvestrant • Orserdu (elacestrant) • Tasfygo (tasurgratinib)
    9ms
    A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene Positivity Who Progressed After Chemotherapy (clinicaltrials.gov)
    P=N/A, N=60, Not yet recruiting, Eisai Co., Ltd. | Trial completion date: Nov 2033 --> Nov 2030 | Initiation date: Feb 2025 --> Aug 2025 | Trial primary completion date: Nov 2032 --> Nov 2030
    Trial completion date • Trial initiation date • Trial primary completion date
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    Tasfygo (tasurgratinib)
    9ms
    Tasurgratinib Succinate: First Approval. (PubMed, Drugs)
    The approval was based on the positive results of an open-label, single-arm, multicenter, phase II study conducted in Japan and China. This article summarizes the milestones in the development of tasurgratinib succinate leading to this first approval for biliary tract cancer.
    Review • Journal
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    FGFR2 (Fibroblast growth factor receptor 2)
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    FGFR2 fusion
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    Tasfygo (tasurgratinib)
    10ms
    A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene Positivity Who Progressed After Chemotherapy (clinicaltrials.gov)
    P=N/A, N=60, Not yet recruiting, Eisai Co., Ltd.
    New trial
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    Tasfygo (tasurgratinib)
    1year
    A Study of E7090 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Estrogen Receptor Positive (ER+) and Human Epidermal Growth Receptor 2 Negative (HER2-) Recurrent/Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=72, Active, not recruiting, Eisai Co., Ltd. | Trial completion date: Dec 2024 --> Mar 2026 | Trial primary completion date: Dec 2024 --> Mar 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • FGFR (Fibroblast Growth Factor Receptor)
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    HER-2 negative
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    fulvestrant • exemestane • Tasfygo (tasurgratinib)
    1year
    A Study of E7090 in Participants With Unresectable Advanced or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor (FGFR) 2 Gene Fusion (clinicaltrials.gov)
    P2, N=63, Active, not recruiting, Eisai Co., Ltd. | Trial completion date: Sep 2024 --> Mar 2026 | Trial primary completion date: Sep 2024 --> Mar 2026
    Trial completion date • Trial primary completion date • Metastases
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    FGFR2 (Fibroblast growth factor receptor 2)
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    FGFR2 fusion
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    Tasfygo (tasurgratinib)
    1year
    Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants (clinicaltrials.gov)
    P1, N=18, Recruiting, Eisai Co., Ltd. | Trial completion date: Nov 2024 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2026
    Trial completion date • Trial primary completion date
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    Tasfygo (tasurgratinib)