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The first targeted pill for bladder cancer, for the roughly 20% of tumours with FGFR3 alterations, used after immunotherapy.
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.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
Pan-FGFR (1-4) tyrosine kinase inhibitor. Connects to FGFR2.
1.Oral absorption; dose titrated to serum phosphate
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. FGFR3 alteration by an approved test.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA1062. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC), that has: susceptible FGFR3 or FGFR2 genetic alterations, and progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA.
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC), that has: susceptible FGFR3 or FGFR2 genetic alterations, and progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA.
Confirmed: the accelerated approval of 2019 converted to traditional approval 4.8 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| 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) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Hyperphosphataemia | 79% | - |
| Stomatitis | 58% | - |
| Diarrhoea | 55% | - |
| Central serous retinopathy | 17% | - |
| Onycholysis | 23% | - |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Erdafitinib" OR ABSTRACT:"Erdafitinib" OR TITLE:"Balversa" OR ABSTRACT:"Balversa") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Erdafitinib, not a curated reading list.
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