# Nadofaragene firadenovec

Source: https://onco.cc/drugs/nadofaragene-firadenovec/  
OnCo record `nadofaragene-firadenovec` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Adstiladrin
- Modality: Non-replicating adenoviral gene therapy (intravesical)
- Mechanism: Adenovirus vector delivers the IFN-α2b gene to urothelial cells, which secrete interferon locally.
- Approvals: US 2022: BCG-unresponsive high-risk NMIBC with CIS ± papillary tumours; EU 2026: BCG-unresponsive NMIBC with CIS; 28 May 2026 (conditional)
- Dosing: Intravesical; 75 mL once every 3 months
- Toxicity (grade 3+): Grade 3+ treatment-related 4%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Nadofaragene_firadenovec
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Nadofaragene%20firadenovec

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Non-muscle-invasive bladder cancer](https://onco.cc/cancers/non-muscle-invasive-bladder-cancer/)
- technologies: [Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)](https://onco.cc/technologies/bcg-and-intravesical-therapy/), [Oncolytic viruses](https://onco.cc/technologies/oncolytic-virus/)
- companies: [Ferring Pharmaceuticals](https://onco.cc/companies/ferring/)
- terms: [BCG-unresponsive](https://onco.cc/terms/bcg-unresponsive/)
- trials: [A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer](https://onco.cc/trials/nct06545955/), [Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer](https://onco.cc/trials/nct06510374/)
- ideas: [Oncolytic viruses that make interleukin-12 only inside the tumour](https://onco.cc/ideas/idea-bio2-oncolytic-regulated-il12/)
- key papers: [Nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer](https://onco.cc/key-papers/paper-nadofaragene-firadenovec-lancet-oncol-2021/)
- drugs: [Valrubicin](https://onco.cc/drugs/valrubicin/)
- roadmaps: [Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants](https://onco.cc/roadmaps/devices-roadmap/)

---
JSON: https://onco.cc/api/v1/entities/nadofaragene-firadenovec.json