Drugs / Erdafitinib
last change Aug 2026 re-read 9 days ago

Erdafitinib

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

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 · 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 · urinary bladder 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 · 6 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed urothelial carcinoma 3 milestones
Filed EU (EMA) — urothelial carcinoma 2023-09-08

“announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of erdafitinib” jnj.com ↗

“marketing authorisationsubmittedto the EMA in September 2023” jnj.com ↗

Filed US (FDA) BALVERSA® urothelial carcinoma 2023-08-29

“On August 29, Janssen submitted a supplemental New Drug Application (sNDA) to the U.S. FDA seeking full approval of erdafitinib in this indication” jnj.com ↗

Filed US (FDA) — urothelial carcinoma 2018-09-18

“A New Drug Application was submitted to the FDA for esketamine nasal spray, a rapidly acting antidepressant for treatment-resistant depression in adults and erdafitinib” jnj.com ↗

“Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer” jnj.com ↗

Approved Indication not stated 3 milestones
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 40

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 · 1 met primary
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 Stop: Enrollment
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 Met primary
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 Active not 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 · 1 met primary
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 2027 expected 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 Stop: Enrollment
Phase 2 NCT04172675 Feb 2020 → Jul 2024 urinary bladder neoplasm Janssen Research & Development, LLC Completed Met primary
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 32 trials
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
Comparator or background therapy1 trial
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

News releases announcing trial results or a regulatory action · 27

DateIssuerRelease
2026-03-13 Janssen Research & Development, LLC Results Johnson & Johnson highlights promising first-in-human Erda-iDRS (formerly TAR-210) results in intermediate‑risk non–muscle-invasive bladder cancer jnj.com ↗
The study met its primary safety endpoint and demonstrated complete and durable responses in patients with recurrent intermediate-risk disease, along with encouraging recurrence-free outcomes in high-risk disease.
2026-03-13 Janssen Research & Development, LLC Results Johnson & Johnson highlights promising first-in-human Erda-iDRS (formerly TAR-210) results in intermediate-risk non-muscle-invasive bladder cancer jnj.com ↗
2024-08-23 Janssen Research & Development, LLC Regulatory European Commission approves BALVERSA®▼ (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved BALVERSA®▼(erdafitinib) as a once-daily oral monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (mUC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting.
2024-08-23 Janssen Research & Development, LLC Regulatory European Commission approves BALVERSA®▼ (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma jnj.com ↗
European Commission approves BALVERSA®▼ (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma
2024-06-28 Janssen Research & Development, LLC Regulatory CHMP adopts positive opinion for BALVERSA® (erdafitinib) for the treatment of adult patients jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation for BALVERSA®(erdafitinib) as a once-daily oral monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting.
2024-06-28 Janssen Research & Development, LLC Regulatory CHMP adopts positive opinion for BALVERSA® (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations jnj.com ↗
CHMP adopts positive opinion for BALVERSA® (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
2024-01-19 Janssen Research & Development, LLC Regulatory U.S. Food and Drug Administration Grants Full Approval for BALVERSA® to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations jnj.com ↗
This FDA action converts the April 2019accelerated approvalof BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study.
2024-01-19 Janssen Research & Development, LLC Regulatory U.S. Food and Drug Administration Grants Full Approval for BALVERSA® to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations jnj.com ↗
U.S. Food and Drug Administration Grants Full Approval for BALVERSA® to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations
2023-10-22 Janssen Research & Development, LLC Results First Results with Erdafitinib-Releasing Intravesical Delivery System (TAR-210) Show Early Evidence of Positive Clinical Activity in Patients with Non-Muscle-Invasive Bladder Cancer with Select Fibroblast Growth Factor Receptor Alterations jnj.com ↗
In C3, 87 percent of the 27 patients having at least one response assessment with IR NMIBC achieved a complete response (CR).
2023-10-22 Janssen Research & Development, LLC Results First Results with Erdafitinib-Releasing Intravesical Delivery System (TAR-210) Show Early Evidence of Positive Clinical Activity in Patients with Non-Muscle-Invasive Bladder Cancer with Select Fibroblast Growth Factor Receptor Alterations jnj.com ↗
Phase 1 results show a manageable safety profile with limited systemic toxicity, and early complete responses in patients with high-risk and intermediate-risk NMIBC
2023-10-21 Janssen Research & Development, LLC Results Results from Phase 2 THOR-2 Study Show Improved Rates of Recurrence-Free Survival in Patients with High-Risk Non-Muscle-Invasive Bladder Cancer with Select Fibroblast Growth Factor Receptor Alterations Treated with BALVERSA® (erdafitinib) Versus Chemotherapy jnj.com ↗
The six-month RFS in patients randomized to BALVERSA®was 96 percent compared to 73 percent in those assigned to chemotherapy.
2023-10-21 Janssen Research & Development, LLC Results Results from Phase 2 THOR-2 Study Show Improved Rates of Recurrence-Free Survival in Patients with High-Risk Non-Muscle-Invasive Bladder Cancer with Select Fibroblast Growth Factor jnj.com ↗
Data from Cohort 1 of the Phase 2 THOR-2 study showed oral erdafitinib reduced the risk of disease recurrence or death compared with intravesical standard-of-care chemotherapy

All press releases naming this drug 31 releases

DateIssuerRelease

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 45 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 ↗

NCT02925234 ↗

NCT05859334 ↗

NCT06351371 ↗

NCT03135106 ↗

NCT03547037 ↗

NCT04172675 ↗

NCT04754425 ↗

Show 25 more sources

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

NCT02218073 ↗

NCT02952573 ↗

NCT02466815 ↗

NCT02692677 ↗

NCT02231489 ↗

NCT02421185 ↗

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 ↗
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