Erdafitinib
The first targeted pill for bladder cancer, for the roughly 20% of tumours with FGFR3 alterations, used after immunotherapy.
Accelerated approval 2019 (BLC2001, ORR 40%); full approval January 2024 on THOR cohort 1 (OS 12.1 vs 7.8 months after chemotherapy and IO). Requires FGFR3/2 alteration testing. Hyperphosphataemia and central serous retinopathy need monitoring. Johnson & Johnson.
1.Oral absorption; dose titrated to serum phosphate
- Route
- Oral
- Schedule
- 8 mg daily, up-titrated to 9 mg if serum phosphate <5.5 mg/dL at day 14
- Dose modifications
- Hold for phosphate >7 mg/dL or ocular toxicity
- Monitoring
- Phosphate monthly; ophthalmology exam monthly for 4 months
- Medicare
- Part D (self-administered)
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).
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Johnson & Johnson withMe
- Johnson & Johnson Patient Assistance Foundation
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Notes
- EU-licensed 2024 for FGFR3-altered urothelial cancer after a PD-1/PD-L1 inhibitor; UK licence and NICE position not yet researched.
Sources: NICE search: erdafitinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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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