Erdafitinib
- Generic Name
- Erdafitinib
- Brand Names
- Balversa
- Drug Type
- Small Molecule
- Chemical Formula
- C25H30N6O2
- CAS Number
- 1346242-81-6
- Unique Ingredient Identifier
- 890E37NHMV
- Background
In early April of 2019, the US FDA approved Janssen Pharmaceutical Companies' brand name Balversa (erdafitinib) as the first-ever fibroblast growth factor receptor (FGFR) kinase inhibitor indicated for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or followin...
- Indication
Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor that is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has susceptible FGFR3 or FGFR2 genetic alterations and has progressed during or following at least one line of prior platinum-containing chemotherapy includ...
- Associated Conditions
- Locally Advanced or Metastatic Urothelial Carcinoma (UC)
- Associated Therapies
- -
A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants
- First Posted Date
- 2020-04-01
- Last Posted Date
- 2023-06-29
- Target Recruit Count
- 15
- Registration Number
- NCT04330248
- Locations
- ๐ง๐ช
Clinical Pharmacology Unit, Merksem, Belgium
A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guรฉrin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
- Conditions
- Interventions
- First Posted Date
- 2019-11-21
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 107
- Registration Number
- NCT04172675
- Locations
- ๐บ๐ธ
Urological Associates of Southern Arizona, P.C., Tucson, Arizona, United States
๐บ๐ธUSC Institute of Urology, Los Angeles, California, United States
๐บ๐ธThe Urology Center of Colorado, Denver, Colorado, United States
A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
- First Posted Date
- 2019-09-10
- Last Posted Date
- 2024-08-14
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 316
- Registration Number
- NCT04083976
- Locations
- ๐ง๐ช
Grand Hopital de Charleroi, site Notre Dame, Charleroi, Belgium
๐ง๐ชCHU UCL Namur - Site Dinant, Dinant, Belgium
๐ง๐ชUZA, Edegem, Belgium
Erdafitinib and Abiraterone Acetate or Enzalutamide in Treating Patients With Double Negative Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2019-06-26
- Last Posted Date
- 2023-09-28
- Lead Sponsor
- University of Washington
- Target Recruit Count
- 3
- Registration Number
- NCT03999515
- Locations
- ๐บ๐ธ
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
FGFR Inhibitor in FGFR Dysregulated Cancer
- Conditions
- Interventions
- First Posted Date
- 2019-02-04
- Last Posted Date
- 2023-06-09
- Lead Sponsor
- Lung Cancer Group Cologne
- Target Recruit Count
- 22
- Registration Number
- NCT03827850
- Locations
- ๐ฉ๐ช
University Hospital of Cologne, Cologne, NRW, Germany
๐ฉ๐ชEvangelische Lungenklink Berlin, Berlin, Germany
๐ฉ๐ชUniklinik Carl Gustav Carus Dresden, Dresden, Sachsen, Germany
Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options
- First Posted Date
- 2019-01-31
- Last Posted Date
- 2019-05-13
- Lead Sponsor
- Janssen Scientific Affairs, LLC
- Registration Number
- NCT03825484
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib
- First Posted Date
- 2018-07-16
- Last Posted Date
- 2021-04-01
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 26
- Registration Number
- NCT03587363
- Locations
- ๐ฉ๐ช
CRS Clinical Research Services Kiel GmbH, Kiel, Germany
๐ฉ๐ชAPEX GmbH, Munchen, Germany
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
- First Posted Date
- 2018-06-06
- Last Posted Date
- 2022-11-07
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Target Recruit Count
- 22
- Registration Number
- NCT03547037
- Locations
- ๐ฏ๐ต
National Cancer Center Hospital East, Kashiwa, Japan
๐ฏ๐ตNational Cancer Center Hospital, Chuo-Ku, Japan
A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer
- Conditions
- Interventions
- First Posted Date
- 2018-03-22
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 125
- Registration Number
- NCT03473743
- Locations
- ๐บ๐ธ
Rocky Mountain Cancer Centers, Aurora, Colorado, United States
๐บ๐ธToledo Clinic Cancer Centers, Toledo, Ohio, United States
๐บ๐ธPenn State Hershey Cancer Institute, Hershey, Pennsylvania, United States
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
- Conditions
- Interventions
- First Posted Date
- 2018-01-04
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 629
- Registration Number
- NCT03390504
- Locations
- ๐จ๐ฆ
Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
๐บ๐ธUniversity of Miami Sylvester Cancer Center, Miami, Florida, United States
๐บ๐ธOncology Hematology Care, Cincinnati, Ohio, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.