Loading
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.
Nadofaragene firadenovec is a non-replicating adenoviral gene therapy: the vector delivers the IFN-alpha2b gene to urothelial cells, which then secrete interferon locally for weeks. It is given as a bladder instillation once every 3 months. In the phase 3 study (Boorjian 2021), 53% of patients with BCG-unresponsive carcinoma in situ had a complete response at 3 months, and 46% of responders maintained it at 12 months. The FDA approved it in December 2022, and Ferring launched commercially in 2023 to 2024 after manufacturing scale-up. Fatigue and bladder spasm were the main side effects, with grade 3 or higher treatment-related events in 4%, and it competes with nogapendekin alfa and TAR-200 in the same setting. It is the first gene therapy for bladder cancer, turning the bladder lining into its own interferon factory.
Adenovirus vector delivers the IFN-α2b gene to urothelial cells, which secrete interferon locally.
1.Instilled with Syn3 excipient to enhance transduction
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.
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.
Sources: NICE search: nadofaragene firadenovec. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
| Region | Year | Indication |
|---|---|---|
| US | 2022 | BCG-unresponsive high-risk NMIBC with CIS ± papillary tumours |
| EU | 2026 | BCG-unresponsive NMIBC with CIS; 28 May 2026 (conditional) · Conditional marketing authorisation |
| 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.
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Query for this drug: (TITLE:"Nadofaragene firadenovec" OR ABSTRACT:"Nadofaragene firadenovec" OR TITLE:"Adstiladrin" OR ABSTRACT:"Adstiladrin") 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 Nadofaragene firadenovec, not a curated reading list.
Shares BCG-unresponsive, Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Non-muscle-invasive bladder cancer, Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants.
Shares BCG-unresponsive, Oncolytic viruses that make interleukin-12 only inside the tumour, Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Non-muscle-invasive bladder cancer.
Shares Nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer, Non-muscle-invasive bladder cancer, Bladder & urothelial cancer.
Shares BCG-unresponsive, Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants, Bladder & urothelial cancer.
Shares Ferring Pharmaceuticals, Non-muscle-invasive bladder cancer, Bladder & urothelial cancer.
Shares BCG-unresponsive, Oncolytic viruses, Bladder & urothelial cancer.
Shares Valrubicin, BCG-unresponsive, Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Non-muscle-invasive bladder cancer.