Erdafitinib

Clinical Trials Overview

1 trials found
About Erdafitinib

Erdafitinib is used in the treatment of advanced or metastatic urothelial carcinoma with FGFR alterations. It has shown efficacy in clinical trials for patients who have progressed on or are intolerant to platinum-containing chemotherapy and have an FGFR genetic alteration. Erdafitinib is not currently approved by the FDA specifically for colorectal cancer, but it is under investigation for other solid tumors.

Category Targeted Therapy
Brand Name ** Balversa® (brand name) / Erdafitinib (generic) **
Mechanism Erdafitinib is a small molecule inhibitor of FGFR1-4, which blocks the activation and dimerization of fibroblast growth factor receptors (FGFRs), thereby inhibiting downstream signaling pathways such as MAPK/ERK and PI3K/AKT/mTOR that are involved in cell proliferation and survival.
Efficacy Data by Mutation
Response rates and survival outcomes by patient molecular profile
FGFR3 FGFR3-TACC3 Level 2B
25%
ORR
5m
PFS
n=5
Sample
FGFR2 High level Level 3
12%
ORR
3m
PFS
n=15
Sample
FGFR1 High level Level 3
8%
ORR
2.5m
PFS
n=12
Sample
1
Total Trials
0
Recruiting
1
Active
0
Completed
6,452
Total Enrollment
3
Countries
NCT02465060 Phase 2 Active 6,452 patients
Start: Aug 2015
End: Dec 2026
INTERVENTIONAL
This phase II MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in patients with solid tumors, lymphomas, or multiple myelomas that may have spread from where it first started to nearby tissue, l...
United States, Guam, Puerto Rico