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
-
Clinical Trials
Related News
targetedonc.com
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FGFR-Altered NMIBC Treatment Advances With TAR-210 Findings

TAR-210, an erdafitinib intravesical delivery system, showed early clinical activity in patients with FGFR-altered high- and intermediate-risk NMIBC. The 12-month recurrence-free survival rate was 90% in high-risk NMIBC patients, with only 2 recurrences out of 21. In intermediate-risk NMIBC patients, the 12-week complete response rate was 90%, with 86% of these responses ongoing at data cutoff. The system aims to reduce systemic toxicities while maintaining efficacy.

Related Clinical Trials:

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
insights.citeline.com
·

Japan Recommends Approval Of Brukinza, Balversa

Japan recommends approval of Brukinza and Balversa, grants Sakigake status to Brogidirsen and Iclepertin, including a DMD gene therapy from public collaboration. PMDA opens a new full-time office in the US.
pharmtech.com
·

J&J's Balversa Gains MHRA Marketing Authorization as Monotherapy for Bladder Cancer

J&J's Balversa (erdafitinib) granted UK marketing authorization for treating unresectable or metastatic urothelial carcinoma with FGFR3 alterations, after prior PD-1/PD-L1 inhibitor therapy. Based on Phase III THOR study, erdafitinib showed improved overall and progression-free survival compared to chemotherapy.
pmlive.com
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Johnson & Johnson's Balversa granted MHRA approval in bladder cancer

J&J's Balversa granted UK marketing authorisation for treating unresectable or metastatic urothelial carcinoma with FGFR3 alterations, after positive THOR trial results showing improved survival and response rates compared to chemotherapy.
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