Data updated: Jun 28, 2026
ERDAFITINIB · NATCO PHARMA
Oncology
Approved 2019-04-12
ERDAFITINIB is FDA-approved to treat 1 condition (same as BALVERSA).
Source: FDA Label
Details
- Status
- Prescription
- First Approved
- 2019-04-12
- Routes
- N/A
- Dosage Forms
- TABLET
ERDAFITINIB Approval History
No approval records found
What ERDAFITINIB Treats
1 indicationsERDAFITINIB is approved for 1 conditions . These indications span multiple therapeutic areas including oncology, immunology, and more.
- Urothelial Carcinoma
Same approved indications as BALVERSA (same active ingredient).
Source: FDA Label
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Clinical Trial Registry
25 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT05859334 | NCI-2023-03776 NCI-2023-03776, 10559 | Ph 2 | recruiting | Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment |
| NCT04963153 | NCI-2021-07069 NCI-2021-07069, MCC 21460 | Ph 1 | active not recruiting | Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy |
| NCT03210714 results posted | NCI-2017-01159 NCI-2017-01159, APEC1621B | Ph 2 | active not recruiting | 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) |
| NCT03390504 THOR results posted | CR108401 42756493BLC3001, 2017-002932-18 | Ph 3 | active not recruiting | 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 |
| NCT02365597 results posted | CR105065 42756493BLC2001, 2014-002408-26 | Ph 2 | active not recruiting | An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer |
| NCT03155620 results posted | NCI-2017-01251 NCI-2017-01251, APEC1621SC | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) |
| NCT04083976 RAGNAR results posted | CR108661 42756493CAN2002, 2019-002113-19 | Ph 2 | completed | A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations |
| NCT04917809 | 21-166 | Ph 2 | active not recruiting | A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer |
| NCT06351371 results posted | NCI-2024-01153 NCI-2024-01153, EAY131-K2 | Ph 2 | active not recruiting | Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2) |
| NCT06308822 results posted | NCI-2024-01151 NCI-2024-01151, EAY131-K1 | Ph 2 | active not recruiting | Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Amplifications (MATCH-Subprotocol K1) |
| NCT03473743 results posted | CR108445 42756493BLC2002, 2017-001980-19 | Ph 1, Ph 2 | active not recruiting | A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer |
| NCT04172675 results posted | CR108699 42756493BLC2003, 2019-002449-39 | Ph 2 | completed | A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) |
| NCT04754425 | 2020-0953 NCI-2021-00663, 2020-0953 | Ph 2 | terminated | Erdafitinib for the Treatment of Patients With Castration-Resistant Prostate Cancer |
| NCT05564416 | NCI-2022-08062 NCI-2022-08062, 10517 | Ph 2 | withdrawn | Testing Anti-Cancer Drugs Erdafitinib With or Without Atezolizumab in Patients With Localized Bladder Cancer Not Able to Receive Cisplatin Chemotherapy, NERA Trial |
| NCT03547037 | CR108471 63723283LUC1002 | Ph 1 | completed | A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-Programmed Cell Death (PD)-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Participants With Advanced Solid Cancers |
| NCT02699606 | CR108120 42756493LUC2001 | Ph 2 | completed | A Study to Evaluate the Clinical Efficacy of JNJ-42756493 (Erdafitinib), A Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, In Asian Participants With Advanced Non-Small-Cell Lung Cancer, Urothelial Cancer, Esophageal Cancer Or Cholangiocarcinoma |
| NCT03135106 | CR108299 2017-000117-23, 42756493EDI1007 | Ph 1 | completed | A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants |
| NCT03587363 | CR108483 2018-001104-11, 42756493EDI1008 | Ph 1 | terminated | A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib |
| NCT03238196 results posted | VICC BRE 16126 | Ph 1 | completed | Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer |
| NCT02925234 DRUP | M15DRU | Ph 2 | recruiting | The Drug Rediscovery Protocol (DRUP Trial) |
| NCT03999515 results posted | RG1005038 NCI-2019-03812, 10288 | Ph 2 | terminated | Erdafitinib and Abiraterone Acetate or Enzalutamide in Treating Patients With Double Negative Prostate Cancer |
| NCT04330248 | CR108763 2019-003473-26, 42756493NAP1001 | Ph 1 | completed | A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants |
| NCT03827850 FIND | Uni-Koeln-3254 2018-000399-13 | Ph 2 | terminated | FGFR Inhibitor in FGFR Dysregulated Cancer |
| NCT03066687 | CR108289 42756493EDI1006 | Ph 1 | completed | A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ERDAFITINIB FDA Label Details
Indications & Usage
ERDAFITINIB is FDA-approved to treat 1 condition — same approved indications as BALVERSA.
Looking for the branded version?
BALVERSA
Full clinical data, patents, trials, and competitive landscape for erdafitinib.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.