# Erdafitinib

Source: https://onco.cc/drugs/erdafitinib/  
OnCo record `erdafitinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first targeted pill for bladder cancer, for the roughly 20% of tumours with FGFR3 alterations, used after immunotherapy.

## Summary

Erdafitinib is an oral pan-FGFR (1 to 4) tyrosine kinase inhibitor for the roughly 20% of urothelial cancers with FGFR3 or FGFR2 alterations, so molecular testing is required before use. It received accelerated approval in 2019 on BLC2001 (ORR 40%) and full approval in January 2024 on THOR cohort 1, where it gave OS 12.1 versus 7.8 months (HR 0.64) against chemotherapy after platinum and immunotherapy. THOR cohort 2, against pembrolizumab in immunotherapy-naive patients, showed no benefit, so the drug is positioned after a PD-1 or PD-L1 inhibitor. Hyperphosphataemia (79%), stomatitis (58%) and central serous retinopathy (17%) need monitoring, including regular eye examinations. Johnson & Johnson develops it. It is the first targeted pill in bladder cancer, and it only works when the tumour carries the matching alteration.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Balversa
- Modality: Small-molecule kinase inhibitor (pan-FGFR)
- Mechanism: Pan-FGFR (1-4) tyrosine kinase inhibitor.
- Approvals: US 2019: FGFR3/2-altered advanced urothelial cancer after platinum (accelerated); US 2024: FGFR3-altered advanced urothelial cancer after ≥1 systemic therapy incl. PD-1/PD-L1 (full)
- Dosing: Oral; 8 mg daily, up-titrated to 9 mg if serum phosphate <5.5 mg/dL at day 14

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Erdafitinib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Erdafitinib

## Connected records

- biomarkers: [FGFR3 alteration (mutation or fusion)](https://onco.cc/biomarkers/fgfr3-alteration/)
- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Muscle-invasive and advanced bladder cancer](https://onco.cc/cancers/muscle-invasive-bladder-cancer/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [FGFR1](https://onco.cc/targets/fgfr1/), [FGFR2](https://onco.cc/targets/fgfr2/), [FGFR3](https://onco.cc/targets/fgfr3-receptor/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- pathways: [Bladder cancer (KEGG map)](https://onco.cc/pathways/bladder-cancer-signalling/), [FGF / FGFR signalling](https://onco.cc/pathways/fgfr-signalling/), [Proteoglycans in cancer](https://onco.cc/pathways/proteoglycans-in-cancer/)
- terms: [FGFR3 alterations (bladder cancer)](https://onco.cc/terms/fgfr3/), [Ocular toxicity (keratopathy, blurred vision)](https://onco.cc/terms/ocular-toxicity/)
- trials: [A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer](https://onco.cc/trials/nct03473743/), [An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer](https://onco.cc/trials/nct02365597/), [NCI-COG Pediatric MATCH (APEC1621)](https://onco.cc/trials/pediatric-match/), [Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer](https://onco.cc/trials/nct05316155/), [THOR](https://onco.cc/trials/thor/)
- drugs: [therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF)](https://onco.cc/drugs/therascreen-cdx/)

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