FGFR3 alteration (mutation or fusion)

Approved therapies

Approvals in the United States (FDA) and the European Union (EMA), one row per drug, regimen and tumour type. Where we have them, the pivotal trial's results and side effects are shown under each therapy, from the official label. Results from different trials are not directly comparable: patients, earlier treatments and comparators differ.

Companion diagnostic tests

Tests the FDA has approved to select patients for a specific therapy. Other validated tests are often used in practice, especially in Europe.

Drugs in active trials

Targeted drugs, antibody-drug conjugates and immunotherapies in active trials on this page, approved ones first, then by the furthest phase reached. Chemotherapy and supportive medicines are left out. "Not yet classified" means an early drug known only by its code.

23 of 23 drugs shown

Upcoming readouts

Active phase 2 and 3 trials whose primary completion date falls in the next 12 months: the date the main results are due to be collected, according to the sponsor. Results are usually published months later, and these dates often slip.

Companies

Industry sponsors leading active trials, by number of trials. Each square is one trial, shaded by phase.

1. Johnson & Johnson 6
2. Tyra Biosciences 3
3. Abbisko Therapeutics 2
4. Eli Lilly 2
5. TransThera Sciences 1
6. Cogent Biosciences 1
7. AstraZeneca 1
8. Biohaven Therapeutics 1

Phase 1 Phase 2 Phase 3 Phase 4 No phase

Trials

Matched automatically from registry text, so a few trials may only mention FGFR3 alteration (mutation or fusion) rather than require it. Check the quoted criterion, and the registry entry before relying on a match.

30 of 98 trials shown

1. A Study of Vepugratinib (LY3866288) in Adults With Non-Muscle Invasive Bladder Cancer and Upper Tract Urothelial Cancer

   Not yet recruiting Phase 2 Eli Lilly Started 2026Primary completion 2028-07 NCT07827612

   Vepugratinib

   Have a documented qualifying fibroblast growth factor receptor 3 protein (FGFR3) mutation or fusion

   Urinary Bladder Neoplasms, Urologic Neoplasms, Receptor, Fibroblast Growth Factor, Type 3

2. Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

   Recruiting Phase 2 Tyra Biosciences Started 2025Primary completion 2028-02 NCT06995677

   TYRA-300

   Documented activating FGFR3 alteration (mutation or fusion)

   Low-grade NMIBC, FGFR Gene Amplification, FGFR Gene Alterations, FGFR3 Gene Alteration

3. A Phase 2 Clinical Study of ABSK061 and ABSK043

   Recruiting Phase 2 Abbisko Therapeutics Started 2024Primary completion 2029-11 NCT06632262

   ABSK061CAPOX

   …cified a central laboratory or previous test report confirming the presence of a specific FGFR3 mutation or overexpression, FGFR2/3 fusion in tumor tissue or blood based on central laboratory te…

   HER2-Gastric/Gastroesophageal Junction Cancer, Urothelial Carcinoma, Non-Small Cell Lung Cancer, Solid Tumors

4. A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer

   Active, not recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2022Primary completion 2027-08 NCT04917809

   erdafitinib FDA EU

   Documentation on MSK-IMPACT of an oncogenic FGFR3 mutation (R248C, S249C, G370C, Y373C, etc.) or FGFR3 gene fusion with compelling clinical or biolo…

   Bladder Cancer, Recurrent Bladder Cancer, FGFR3 Gene Mutation

5. Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations

   Active, not recruiting Phase 1/2 Tyra Biosciences Started 2022Primary completion 2026-11 NCT05544552

   TYRA-300

   Histologically confirmed advanced solid tumor with an eligible FGFR3 gene mutation or fusion (Part B).

   Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Solid Tumor, Urothelial Carcinoma

6. A Phase 1 Study of BHV-1530 in Advanced Solid Tumors

   Recruiting Phase 1 Biohaven Therapeutics Started 2025Primary completion 2029-03 NCT06874335

   BHV-1530cemiplimab

   Other advanced or metastatic solid tumors with a documented activating FGFR3 alteration (mutation or fusion).

   Solid Tumor

7. FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3

   Recruiting Phase 1 Eli Lilly Started 2023Primary completion 2027-06 NCT05614739

   Vepugratinibpembrolizumabenfortumab vedotintrastuzumab deruxtecanmidazolamDigoxinRosuvastatin

   …, C1, D1, and D2: Locally advanced or metastatic solid tumor malignancy with a qualifying FGFR3 alteration.

   Urinary Bladder Neoplasms, Neoplasm Metastasis, Ureteral Neoplasms

8. A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK121-NX in Patients With Advanced Solid Tumors

   Active, not recruiting Phase 1 Abbisko Therapeutics Started 2023Primary completion 2026-03 NCT05627063

   ABSK121-NX

   Urothelial carcinoma (UC): pre-specified FGFR3 mutations (R248C, S249C, G370C, Y373C) or FGFR2/3 fusions (partner gene is previously described or …

   Solid Tumor

9. Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer

   Active, not recruiting Phase 1 AstraZeneca Started 2016Primary completion 2020-03 NCT02546661

   fexagratinibdurvalumabolaparibadavosertibVistusertibAZD9150selumetinib

   Confirmation of FGFR3 mutation or FGFR fusion

   Muscle Invasive Bladder Cancer

10. A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

    Recruiting Phase 3 Johnson & Johnson Started 2025Primary completion 2028-04 NCT06919965

    erdafitinib FDA EUMitomycin Cgemcitabine

    Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as determin…

    Broad match: FGFR alteration (unspecified)Non-Muscle Invasive Bladder Neoplasms

11. A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

    Recruiting Phase 3 Johnson & Johnson Started 2024Primary completion 2028-06 NCT06319820

    erdafitinib FDA EUgemcitabineMMC

    Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determi…

    Broad match: FGFR alteration (unspecified)Non-Muscle Invasive Bladder Neoplasms

12. Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

    Active, not recruiting Phase 3 TransThera Sciences Started 2023Primary completion 2026-12 NCT05948475

    tinengotinibPhysician's Choice

    Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

    Broad match: FGFR alteration (unspecified)Cholangiocarcinoma

13. A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

    Active, not recruiting Phase 3 Johnson & Johnson Started 2018Primary completion 2024-04 NCT03390504

    erdafitinib FDA EUVinfluninedocetaxelpembrolizumab

    …ticipants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

    Broad match: FGFR alteration (unspecified)Urothelial Cancer

14. Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG)

    Not yet recruiting Phase 2 Nationwide Children's Hospital Starts 2027Primary completion 2030-02 NCT07206849

    tovorafenib

    …included in Stratum A (KIAA1549:BRAF fusion, KRAS/NRAS, CRAF/RAF1, other RAF mutation, or FGFR alteration) OR patients with primary spinal tumors.

    Broad match: FGFR alteration (unspecified)High Grade Glioma (HGG) of the Brain With BRAF Aberration, High Grade Glioma (III or IV), Diffuse Intrinsic Pontine Glioma, High Grade Glioma

15. Efficacy of Pemigatinib in Patients With Solid Tumors Characterized by an Alteration of the Gene FGFR in Tumor Cells

    Recruiting Phase 2 UNICANCER Started 2025Primary completion 2027-06 NCT06653777

    pemigatinib

    …nt with locally recurrent unresectable and/or advanced or metastatic disease harbouring a FGFR1,2,3 fusion/rearrangement or mutation

    Broad match: FGFR alteration (unspecified)Solid Tumor, Miscellaneous

16. A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors

    Active, not recruiting Phase 1/2 Cogent Biosciences Started 2025Primary completion 2027-03 NCT06777316

    CGT4859

    …cally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor.

    Broad match: FGFR alteration (unspecified)Intrahepatic Cholangiocarcinoma (Icc), Cholangiocarcinoma, Other Solid Tumors, Adult, FGFR2 Gene Fusion/Rearrangement

17. A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations

    Recruiting Phase 2 Sameek Roychowdhury Started 2025Primary completion 2026-12 NCT06906562

    pemigatinib

    … central Clinical Laboratory Improvement Act (CLIA)-certified laboratory determination of FGFR gene fusions/translocations or activating mutations

    Broad match: FGFR alteration (unspecified)Advanced Pancreatic Carcinoma, Metastatic Pancreatic Carcinoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8

18. Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor

    Not yet recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Started 2024Primary completion 2026-07 NCT06551896

    pemigatinib

    Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor

    Broad match: FGFR alteration (unspecified)Status may be outdated, last updated 2024-08-13Urothelial Carcinoma, Breast Neoplasms, Lung Cancer, Gastric Cancer

19. Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations

    Recruiting Phase 2 Spanish Oncology Genito-Urinary Group Started 2023Primary completion 2026-07 NCT06511648

    erdafitinib FDA EU

    Presence of a selected FGFR alteration on analysis of tumour biopsy

    Broad match: FGFR alteration (unspecified)Muscle-invasive Bladder Cancer

20. Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

    Active, not recruiting Phase 1/2 Johnson & Johnson Started 2022Primary completion 2028-03 NCT05316155

    erdafitinib FDA EU

    For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to th…

    Broad match: FGFR alteration (unspecified)Non-Muscle Invasive Bladder Neoplasms

21. Pemigatinib in the Advanced Gastrointestinal Cancer With FGFR 1-3 Alterations

    Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2022Primary completion 2024-12 NCT05651672

    pemigatinib

    With histologically confirmed FGFR1-3 alterations, including but not limited to amplification, mutation, fusion/rearrangement

    Broad match: FGFR alteration (unspecified)Status may be outdated, last updated 2022-12-15Gastrointestinal Cancer

22. SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma

    Recruiting Phase 1/2 St. Jude Children's Research Hospital Started 2021Primary completion 2031-06 NCT04923126

    mirdametinib

    BRAF fused or rearranged, FGFR1/2/3 aberration, NF1, NF2, PTPN11, SOS1, RAF1 mutations, MYB or MYBL1 fused or rearranged, etc.) or occur…

    Broad match: FGFR alteration (unspecified)Low-Grade Glioma, Recurrent Low-Grade Glioma, Progressive Low-Grade Glioma

23. NCCH2006/MK010 Trial (FORTUNE Trial)

    Recruiting Phase 2 National Cancer Center, Japan Started 2021Primary completion 2028-03 NCT04962867

    tasurgratinib

    Participants with an FGFR gene alteration detected by NGS panel, who fall under one of the categories of groups A to C and E define…

    Broad match: FGFR alteration (unspecified)Advanced or Recurrent Solid Tumors, FGFR Gene Alterations

24. Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2018Primary completion 2022-06 NCT06351371

    erdafitinib FDA EU

    Patients must have FGFR mutation or fusion as determined via the MATCH Master Protocol

    Broad match: FGFR alteration (unspecified)Malignant Solid Neoplasm

25. Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2018Primary completion 2023-09 NCT03210714

    erdafitinib FDA EU

    … or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)

    Broad match: FGFR alteration (unspecified)Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Childhood Medulloblastoma

26. An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

    Active, not recruiting Phase 2 Johnson & Johnson Started 2015Primary completion 2022-09 NCT02365597

    erdafitinib FDA EUmidazolammetformin

    …NJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations

    Broad match: FGFR alteration (unspecified)Urothelial Cancer

27. Pemigatinib + Afatinib in Advanced Refractory Solid Tumors

    Recruiting Phase 1 Massachusetts General Hospital Started 2024Primary completion 2027-12 NCT06302621

    afatinibpemigatinib

    FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions on …

    Broad match: FGFR alteration (unspecified)Advanced Solid Tumor, Unresectable Solid Tumor, Metastatic Solid Tumor, Cholangiocarcinoma

28. A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer

    Active, not recruiting Phase 1 Johnson & Johnson Started 2023Primary completion 2025-03 NCT05567185

    erdafitinib FDA EU

    At least 1 of the study protocol defined activating fibroblast growth factor receptors (FGFR) mutation or fusion, as determined by local or central testing using either tumor tissue or urine s…

    Broad match: FGFR alteration (unspecified)Urinary Bladder Neoplasms, Receptors, Fibroblast Growth Factor

29. Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations

    Active, not recruiting Phase 1 Tyra Biosciences Started 2023Primary completion 2027-03 NCT06160752

    Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cyPhase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cyc

    …histologically confirmed advanced solid tumor with FGFR/FGF pathway alterations including FGFR gene mutations, fusions, and amplifications, as well as gene amplifications of FGFR ligands, who have ex…

    Broad match: FGFR alteration (unspecified)Locally Advanced Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Solid Tumor, Metastatic Cholangiocarcinoma

30. Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy

    Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2022Primary completion 2026-12 NCT04963153

    enfortumab vedotinerdafitinib FDA EU

    …ith Enfortumab Vedotin Following Prior Therapies for Metastatic Urothelial Carcinoma With FGFR2/3 Genetic Alterations

    Broad match: FGFR alteration (unspecified)Locally Advanced Bladder Urothelial Carcinoma, Locally Advanced Renal Pelvis Urothelial Carcinoma, Locally Advanced Ureter Urothelial Carcinoma, Locally Advanced Urethral Urothelial Carcinoma

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