Last reviewed 2026-05-15 · How we verify

Erdafitinib monotherapy

Spanish Oncology Genito-Urinary Group · Phase 2 active Small molecule

Erdafitinib monotherapy is a FGFR inhibitor Small molecule drug developed by Spanish Oncology Genito-Urinary Group. It is currently in Phase 2 development for Locally advanced or metastatic urothelial carcinoma with FGFR alterations, Other FGFR-driven solid tumors.

Erdafitinib is a fibroblast growth factor receptor (FGFR) inhibitor that blocks FGFR signaling in cancer cells.

Erdafitinib is a fibroblast growth factor receptor (FGFR) inhibitor that blocks FGFR signaling in cancer cells. Used for Locally advanced or metastatic urothelial carcinoma with FGFR alterations, Other FGFR-driven solid tumors.

Likelihood of approval

13.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 2 attrition -2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Erdafitinib monotherapy
Sponsor	Spanish Oncology Genito-Urinary Group
Drug class	FGFR inhibitor
Target	FGFR1, FGFR2, FGFR3, FGFR4
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 2

Mechanism of action

Erdafitinib is a pan-FGFR tyrosine kinase inhibitor that targets FGFR1, FGFR2, FGFR3, and FGFR4. By inhibiting FGFR signaling, it suppresses proliferation and survival of cancer cells that depend on aberrant FGFR activation, particularly those with FGFR alterations such as mutations or fusions. This mechanism is especially relevant in urothelial carcinoma and other cancers driven by FGFR dysregulation.

Approved indications

Locally advanced or metastatic urothelial carcinoma with FGFR alterations
Other FGFR-driven solid tumors

Common side effects

Hyperphosphatemia
Diarrhea
Stomatitis
Fatigue
Nausea
Retinal detachment or vision changes

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Erdafitinib monotherapy CI brief — competitive landscape report
Erdafitinib monotherapy updates RSS · CI watch RSS
Spanish Oncology Genito-Urinary Group portfolio CI

Frequently asked questions about Erdafitinib monotherapy

What is Erdafitinib monotherapy?

Erdafitinib monotherapy is a FGFR inhibitor drug developed by Spanish Oncology Genito-Urinary Group, indicated for Locally advanced or metastatic urothelial carcinoma with FGFR alterations, Other FGFR-driven solid tumors.

How does Erdafitinib monotherapy work?

Erdafitinib is a fibroblast growth factor receptor (FGFR) inhibitor that blocks FGFR signaling in cancer cells.

What is Erdafitinib monotherapy used for?

Erdafitinib monotherapy is indicated for Locally advanced or metastatic urothelial carcinoma with FGFR alterations, Other FGFR-driven solid tumors.

Who makes Erdafitinib monotherapy?

Erdafitinib monotherapy is developed by Spanish Oncology Genito-Urinary Group (see full Spanish Oncology Genito-Urinary Group pipeline at /company/spanish-oncology-genito-urinary-group).

What drug class is Erdafitinib monotherapy in?

Erdafitinib monotherapy belongs to the FGFR inhibitor class. See all FGFR inhibitor drugs at /class/fgfr-inhibitor.

What development phase is Erdafitinib monotherapy in?

Erdafitinib monotherapy is in Phase 2.

What are the side effects of Erdafitinib monotherapy?

Common side effects of Erdafitinib monotherapy include Hyperphosphatemia, Diarrhea, Stomatitis, Fatigue, Nausea, Retinal detachment or vision changes.

What does Erdafitinib monotherapy target?

Erdafitinib monotherapy targets FGFR1, FGFR2, FGFR3, FGFR4 and is a FGFR inhibitor.

Drug class: All FGFR inhibitor drugs
Target: All drugs targeting FGFR1, FGFR2, FGFR3, FGFR4
Manufacturer: Spanish Oncology Genito-Urinary Group — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Locally advanced or metastatic urothelial carcinoma with FGFR alterations
Indication: Drugs for Other FGFR-driven solid tumors

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing