Product
Erdafitinib
Aliases
Balversa, ERDA, erdafitinib, Erdafitinib Intravesical Delivery System (1 other aliases)
Name
Erda
Target
pan-FGFR tyrosine kinase
FDA Approved
Yes
Ema approved
Status
0
23 clinical trials
1 organization
1 drug
3 abstracts
84 indications
1 document
Indication
TumorIndication
Bladder CancerIndication
HealthyIndication
Malignant NeoplasmIndication
Non-Hodgkin LymphomaIndication
Stage IV Non-Hodgkin LymphomaIndication
Histiocytic SarcomaIndication
Juvenile XanthogranulomaIndication
Langerhans Cell HistiocytosisIndication
Malignant GliomaIndication
Recurrent Childhood RhabdomyosarcomaIndication
EpendymomaIndication
Ewing SarcomaIndication
Recurrent GliomaIndication
HepatoblastomaIndication
Recurrent Langerhans Cell HistiocytosisIndication
Recurrent Malignant Germ Cell TumorIndication
Recurrent Malignant Solid NeoplasmIndication
MedulloblastomaIndication
NeuroblastomaIndication
OsteosarcomaIndication
Recurrent rhabdoid tumorIndication
Soft Tissue SarcomaIndication
GliomaIndication
Malignant Germ Cell TumorIndication
Malignant Solid NeoplasmIndication
Refractory Non-Hodgkin LymphomaIndication
Rhabdoid TumorIndication
RhabdomyosarcomaIndication
Soft Tissue Sarcoma AJCC v7Indication
Osteosarcoma AJCC v7Indication
Stage IV Soft Tissue Sarcoma AJCC v7Indication
Wilms tumorIndication
Bladder Urothelial CarcinomaIndication
Breast CancerIndication
Ovarian CancerIndication
Steroid Cell TumorIndication
malignantIndication
Renal Pelvis Urothelial CarcinomaIndication
Ureter Urothelial CarcinomaIndication
Urethral Urothelial CarcinomaIndication
Urothelial CarcinomaIndication
Metastatic Bladder Urothelial CarcinomaIndication
Metastatic Urothelial CarcinomaIndication
Recurrent Ureter Urothelial CarcinomaIndication
Recurrent Urethral Urothelial CarcinomaIndication
Recurrent Urothelial CarcinomaIndication
Bladder Cancer AJCC v8Indication
Stage IV Bladder CancerIndication
Stage IV Renal Pelvis CancerIndication
Stage IV Ureter Cancer AJCC v8Indication
Urethral CancerIndication
Bladder Cancer Stage III AJCC v8Indication
Bladder Cancer, Stage IVA (AJCC v8)Indication
LymphomaIndication
Childhood EpendymomaIndication
Germ Cell TumorIndication
Childhood MedulloblastomaIndication
Childhood Non-Hodgkin LymphomaIndication
Recurrent Childhood Soft Tissue SarcomaIndication
Recurrent Malignant GliomaIndication
Childhood Malignant Germ Cell TumorIndication
Childhood OsteosarcomaIndication
Childhood RhabdomyosarcomaIndication
Childhood Soft Tissue SarcomaIndication
Multiple MyelomaIndication
Castration-Resistant Prostate CarcinomaIndication
Prostate CancerIndication
CancerIndication
NeoplasiaIndication
FGFR3 Gene MutationIndication
Bone MetastasisIndication
ReceptorsIndication
FGFIndication
Advanced Solid TumorIndication
GlioblastomaIndication
IDH WildtypeIndication
Recurrent WHO Grade 2 GliomaIndication
Recurrent WHO Grade III GliomaDrug
ErdafitinibClinical trial
A Phase 2a Study to Evaluate The Clinical Efficacy of JNJ-42756493, A Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, In Asian Patients With Advanced Non-Small-Cell Lung Cancer, Urothelial Cancer, Gastric Cancer, Esophageal Cancer Or CholangiocarcinomaStatus: Completed, Estimated PCD: 2021-10-12
Clinical trial
A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic AlterationsStatus: Active (not recruiting), Estimated PCD: 2022-09-15
Clinical trial
An Open-label, Single-sequence, Drug-drug Interaction Study to Evaluate the Effect of Steady-state Carbamazepine on the Single-dose Pharmacokinetics of Erdafitinib Tablets in Healthy Adult SubjectsStatus: Completed, Estimated PCD: 2022-06-14
Clinical trial
A Phase 1/1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Subjects With Advanced Solid CancersStatus: Completed, Estimated PCD: 2022-07-04
Abstract
Erdafitinib (ERDA) vs ERDA plus cetrelimab (ERDA+CET) for patients (pts) with metastatic urothelial carcinoma (mUC) and fibroblast growth factor receptor alterations (FGFRa): Final results from the phase 2 Norse study.Org: Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London, United Kingdom, Department of Urology, Chonnam National University Medical School, Gwangju, South Korea, Janssen Research & Development, Spring House, PA, Gustave Roussy and Paris Saclay University, Villejuif, France, Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX,
Abstract
Erdafitinb in patients with FGFR-altered tumors: Results from the NCI-COG Pediatric MATCH trial arm B (APEC1621B).Org: Weill Cornell Medicine, New York, NY, MD Anderson Cancer Center, Houston, TX, National Cancer Institute, Rockville, MD, Children's Oncology Group, Monrovia, CA, Texas Children's Cancer and Hematology Center, Houston, TX,
Abstract
Phase 3 THOR study: Results of erdafitinib (erda) versus chemotherapy (chemo) in patients (pts) with advanced or metastatic urothelial cancer (mUC) with select fibroblast growth factor receptor alterations (FGFRalt).Org: Department of Medical Oncology, National Cancer Center Hospital East, Chiba, Japan, Section of Radiotherapy and Imaging, Institute of Cancer Research and Royal Marsden NHS Foundation Trust, Sutton, United Kingdom, Medical Oncology Department, Institut de Cancérologie du Gard - CHU Caremeau, Nimes, France, Department of Medical Oncology, Centre Eugene Marquis, Rennes, France, Seoul National University Hospital, Seoul, Korea, Republic of (South),
Clinical trial
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening ProtocolStatus: Recruiting, Estimated PCD: 2027-09-30
Clinical trial
Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Primary Bladder TumorsStatus: Not yet recruiting, Estimated PCD: 2024-07-01
Clinical trial
A Phase Ib Trial of Fulvestrant, Palbociclib (CDK4/6 Inhibitor) and Erdafitinib (JNJ- 42756493,Pan-FGFR Tyrosine Kinase Inhibitor) in ER+/HER2-/FGFR-Amplified Metastatic Breast Cancer (MBC)Status: Active (not recruiting), Estimated PCD: 2021-04-30
Clinical trial
Erdafitinib in Metastatic Steroid-cell Tumor of the Ovary, NOSStatus: Completed, Estimated PCD: 2022-08-22
Clinical trial
Phase Ib Trial of Erdafitinib Combined With Enfortumab Vedotin Following Platinum and PD1/L1 Inhibitors for Metastatic Urothelial Carcinoma With FGFR2/3 Genetic AlterationsStatus: Recruiting, Estimated PCD: 2024-09-01
Clinical trial
Phase 2 Study of Erdafitinib (JNJ-42756493) in Patients With Tumors With FGFR Mutations or FusionsStatus: Active (not recruiting), Estimated PCD: 2024-06-30
Clinical trial
An Open Label, Randomized Phase II Study Neoadjuvant Erdafitinib With or Without Atezolizumab in Cisplatin-Ineligible Patients With Muscle Invasive Bladder Cancer (NERA)Status: Withdrawn, Estimated PCD: 2023-11-03
Clinical trial
Phase 2 Study of JNJ-42756493 (Erdafitinib) in Patients With Tumors With FGFR AmplificationsStatus: Active (not recruiting), Estimated PCD: 2024-06-30
Clinical trial
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of Erdafitinib in Patients With Tumors Harboring FGFR1/2/3/4 AlterationsStatus: Active (not recruiting), Estimated PCD: 2023-09-30
Clinical trial
Erdafitinib Plus Abiraterone Acetate or Enzalutamide in Double Negative Prostate CancerStatus: Terminated, Estimated PCD: 2021-06-06
Clinical trial
A Dutch National Study on Behalf of the CPCT to Facilitate Patient Access to Commercially Available, Targeted Anti-cancer Drugs to Determine the Potential Efficacy in Treatment of Advanced Cancers With a Known Molecular ProfileStatus: Recruiting, Estimated PCD: 2027-09-01
Clinical trial
A Phase 2 "Window of Opportunity" Trial of Targeted Therapy With Erdafitinib in Patients With Recurrent FGFR3-Altered Non-Muscle Invasive Bladder CancerStatus: Recruiting, Estimated PCD: 2025-08-01
Clinical trial
A Study of Erdafitinib in Castration-Resistant Prostate Cancer Patients Evaluating Markers of Bone Remodeling and FGF Signaling in Plasma and Bone MarrowStatus: Active (not recruiting), Estimated PCD: 2026-06-30
Clinical trial
A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial CancerStatus: Active (not recruiting), Estimated PCD: 2022-09-30
Clinical trial
Phase 1 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non- Muscle-Invasive or Muscle-Invasive Bladder Cancer and Selected FGFR Mutations or FusionsStatus: Recruiting, Estimated PCD: 2028-03-30
Clinical trial
A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene AberrationsStatus: Active (not recruiting), Estimated PCD: 2024-09-11
Clinical trial
A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene AlterationsStatus: Active (not recruiting), Estimated PCD: 2023-12-04
Clinical trial
A Phase 2 Study of Erdafitinib in Patients With Recurrent or Progressive IDH-Wild Type Glioma With an FGFR-TACC Gene FusionStatus: Recruiting, Estimated PCD: 2026-10-23
Clinical trial
A Phase 1 Study to Evaluate the Tolerability, Safety, and Pharmacokinetics of TAR-210 in Japanese Participants With Bladder Cancer and Selected FGFR Mutations or FusionsStatus: Recruiting, Estimated PCD: 2026-10-16
Document
DailyMed Label: BALVERSAOrganization
Janssen Products LP