Drugs / Erdafitinib
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Erdafitinib

also known as JNJ-42756493 · TAR-210 · Balversa · ERDA

Small molecule targets FGFR1, FGFR3 via inhibition

Developed for
urothelial carcinoma · infiltrating bladder urothelial carcinoma · neoplasm · plasma cell myeloma · cancer · castration-resistant prostate carcinoma · hepatoblastoma · Langerhans cell histiocytosis
+40 more · lymphoma · malignant glioma · neuroblastoma · non-Hodgkin lymphoma · prostate adenocarcinoma · rhabdoid tumor · rhabdomyosarcoma · urinary bladder cancer · urinary bladder carcinoma · urinary bladder neoplasm · Wilms tumor · adult lymphoma · breast cancer · childhood ependymoma · childhood medulloblastoma · conventional osteosarcoma · ependymoma · Ewing sarcoma · Ewing sarcoma/peripheral primitive neuroectodermal tumor · gastroesophageal junction adenocarcinoma · grade II glioma · grade III glioma · hepatocellular carcinoma · histiocytic sarcoma · juvenile xanthogranuloma · malignant childhood germ cell neoplasm · malignant germ cell tumor · malignant sex cord stromal tumor of ovary · medulloblastoma · metastatic carcinoma in the bone · non-invasive bladder urothelial carcinoma · pediatric osteosarcoma · peripheral primitive neuroectodermal tumor · primary organ-specific lymphoma · prostate carcinoma · prostate small cell carcinoma · refractory malignant neoplasm · refractory plasma cell neoplasm · non-small cell lung carcinoma · squamous cell lung carcinoma
Investigated by
Janssen Research & Development, LLC · National Cancer Institute (NCI) · Eli Lilly and Company · GlaxoSmithKline · Janssen Pharmaceutical K.K. · Janssen, LP
+34 more · Multiple Myeloma Research Consortium · University Health Network, Toronto · AbbVie · Amgen · AstraZeneca · Bayer · Boehringer Ingelheim · Brigham and Women's Hospital · Bristol-Myers Squibb · Celerion · Celgene Corporation · Clovis Oncology - Pharma and · Dutch Cancer Society · Eisai Inc. · Genentech, Inc. · Incyte Corporation · Ipsen · Janssen Scientific Affairs, LLC · Janssen-Cilag Ltd. · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Karyopharm Therapeutics Inc · M.D. Anderson Cancer Center · Memorial Sloan Kettering Cancer Center · Merck Sharp & Dohme LLC · Novartis · Pfizer · Pivotal S.L. · Roche Pharma AG · Spanish Oncology Genito-Urinary Group · Stelvio for Life · Takeda · The Netherlands Cancer Institute · University of Washington · Vanderbilt-Ingram Cancer Center

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Balversa 2024-08-22 europa.eu
Label expansion US (FDA) BALVERSA 2024-01-19 fda.gov
Approved US (FDA) BALVERSA 2019-04-12 fda.gov

Trials 41 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT06204614 Jun 2024 → Jul 2028 expected infiltrating bladder urothelial carcinoma Brigham and Women's Hospital Enrolling by invitation No outcome recorded
Phase 114 trials
Phase 1 NCT05567185 Mar 2023 → Mar 2025 overdue urinary bladder cancer Janssen Pharmaceutical K.K. Active not recruiting No outcome recorded
Phase 1 NCT04963153 Jul 2022 → Dec 2026 expected ureter cancer, urethra cancer, urothelial carcinoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 1 NCT04330248 Mar 2020 → Jun 2022 Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Completed No outcome recorded
Phase 1 NCT03587363 Dec 2018 → Dec 2020 Janssen Research & Development, LLC Terminated No outcome recorded
Phase 1 NCT03547037 Aug 2018 → Jul 2022 neoplasm Janssen Pharmaceutical K.K. Completed No outcome recorded
Phase 1 NCT03238196 Aug 2017 → Apr 2021 breast cancer Vanderbilt-Ingram Cancer Center Completed No outcome recorded
Phase 1 NCT03135106 Apr → Sep 2017 Janssen Research & Development, LLC Completed No outcome recorded
Phase 1 NCT03066687 Mar → May 2017 Janssen Research & Development, LLC Completed No outcome recorded
Phase 1 NCT02692677 Mar → Aug 2016 Janssen Research & Development, LLC Completed No outcome recorded
Phase 1 NCT02466815 Jun → Aug 2015 Janssen Research & Development, LLC Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT05316155 Apr 2022 → Mar 2028 expected non-invasive bladder urothelial carcinoma Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 1/2 NCT03732703 Apr 2019 → Dec 2024 refractory plasma cell neoplasm Multiple Myeloma Research Consortium Completed No outcome recorded
Phase 1/2 NCT03473743 Apr 2018 → Sep 2022 overdue urothelial carcinoma Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 1/2 NCT02421185 May 2015 → May 2019 hepatocellular carcinoma Janssen Research & Development, LLC Completed No outcome recorded
Phase 217 trials
Phase 2 NCT05859334 Jan 2024 → Oct 2026 expected grade II glioma, grade III glioma National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 2 NCT05564416 Oct 2023 → Jan 2024 infiltrating bladder urothelial carcinoma, renal pelvis/ureter urothelial carcinoma National Cancer Institute (NCI) Withdrawn No outcome recorded
Phase 2 NCT06511648 Mar 2023 → Jul 2026 overdue infiltrating bladder urothelial carcinoma Spanish Oncology Genito-Urinary Group Recruiting No outcome recorded
Phase 2 NCT04917809 Feb 2022 → Aug 2026 overdue urinary bladder cancer Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT04754425 Jul 2021 → Feb 2026 castration-resistant prostate carcinoma, metastatic carcinoma in the bone, prostate adenocarcinoma, prostate small cell carcinoma M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 2 NCT03999515 Apr 2020 → Jun 2021 castration-resistant prostate carcinoma, metastatic prostate carcinoma, prostate adenocarcinoma University of Washington Terminated No outcome recorded
Phase 2 NCT04172675 Feb 2020 → Jul 2024 urinary bladder neoplasm Janssen Research & Development, LLC Completed No outcome recorded
Phase 2 NCT04083976 Nov 2019 → Dec 2023 neoplasm Janssen Research & Development, LLC Completed No outcome recorded
Phase 2 NCT06308822 Aug 2018 → Jul 2022 overdue adult lymphoma, plasma cell myeloma, refractory malignant neoplasm National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 2 NCT06351371 Jul 2018 → Jun 2022 overdue cancer National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 33 trials
Phase 3 NCT06919965 Sep 2025 → Apr 2028 expected urinary bladder neoplasm Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 3 NCT06319820 Apr 2024 → Jun 2028 expected urinary bladder carcinoma Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 3 NCT03390504 Mar 2018 → Apr 2024 overdue urothelial carcinoma Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase not applicable1 trial
NCT06328491 May → Aug 2022 malignant sex cord stromal tumor of ovary University Health Network, Toronto Completed No outcome recorded
Phase not stated1 trial
NCT03825484 Janssen Scientific Affairs, LLC Approved for marketing No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT03827850 Comparator Mar 2019 → Sep 2022 non-small cell lung carcinoma, squamous cell lung carcinoma Lung Cancer Group Cologne Terminated No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 46 sources stand behind the page.

FieldValueCited text
Known as erdafitinib “This phase 1, open-label, multicenter, single-arm, dose-escalation study aimed to evaluate safety, pharmacokinetics (PK), and pharmacodynamics of erdafitinib (JNJ-42756493), an...” PMID 28965185 Sep 2017
35

“A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants...” NCT06319820

“Multicenter Phase I Study of Erdafitinib (JNJ-42756493), Oral Pan-Fibroblast Growth Factor Receptor Inhibitor, in Patients with Advanced or Refractory Solid Tumors.” PMID 31088831 May 2019

“JNJ-42756493 (erdafitinib)” NCT02421185

NCT04754425

NCT03547037

NCT03390504

NCT05316155

NCT02365597

NCT03825484

NCT04172675

NCT06308822

NCT05567185

NCT03827850

NCT04083976

NCT03587363

NCT03473743

NCT03066687

NCT03732703

NCT06328491

NCT03999515

NCT03238196

NCT06204614

NCT03155620

NCT04917809

NCT06511648

NCT05564416

NCT05859334

NCT02465060

NCT03135106

NCT04963153

NCT03210714

NCT02699606

NCT06351371

NCT04330248

NCT02925234

Known as Balversa ChEMBL registry synonym — accepted as the source's own label CHEMBL3545376
Known as ERDA Erdafitinib (ERDA) monotherapy” NCT06511648
Known as JNJ-42756493 “This phase 1, open-label, multicenter, single-arm, dose-escalation study aimed to evaluate safety, pharmacokinetics (PK), and pharmacodynamics of erdafitinib (JNJ-42756493), an...” PMID 28965185 Sep 2017
7

“Multicenter Phase I Study of Erdafitinib (JNJ-42756493), Oral Pan-Fibroblast Growth Factor Receptor Inhibitor, in Patients with Advanced or Refractory Solid Tumors.” PMID 31088831 May 2019

NCT02231489

NCT02218073

NCT02466815

NCT02952573

NCT02421185

NCT02692677

Known as TAR-210 “A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants...” NCT06319820
1

NCT06919965

Action Inhibit “pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor” NCT01962532
Modality Small molecule “evaluating the small-molecule FGFR1-4 inhibitor, erdafitinib” PMID 36639200 May 2023
1

CHEMBL3545376

Route Oral “JNJ-42756493 administered orally once daily” NCT01962532
Target FGFR1 “tyrosine kinase inhibitor of FGFR1-4” PMID 31340094 Jul 2019