Nadofaragene firadenovec
Nadofaragene firadenovec is the first gene therapy for bladder cancer: a virus that makes bladder cells produce interferon for weeks, given once every three months.
Phase 3 (Boorjian 2021): CR 53% at 3 months in CIS; 46% of responders maintained at 12 months. FDA approval December 2022; commercial launch 2023-24 after manufacturing scale-up. Ferring.
1.Instilled with Syn3 excipient to enhance transduction
- Route
- Intravesical
- Schedule
- 75 mL once every 3 months
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Intravesical instillation in the urology clinic, quarterly.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments. Plans require BCG-unresponsive NMIBC documented per the label.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: nadofaragene firadenovec. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2022 | BCG-unresponsive high-risk NMIBC with CIS ± papillary tumours |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Fatigue | 24% | — |
| Bladder spasm | 20% | — |
| Micturition urgency | 19% | — |
| Grade 3+ treatment-related | — | 4% |
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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Latest papers
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