{"entity":{"id":"nadofaragene-firadenovec","kind":"drug","name":"Nadofaragene firadenovec","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Nadofaragene_firadenovec","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Nadofaragene%20firadenovec"}],"tags":[],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["bcg-and-intravesical-therapy"],"targets":[],"drugs":[],"companies":["ferring"],"institutions":[],"pathways":[],"terms":["bcg-unresponsive"],"trials":["nct06510374","nct06545955"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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":[{"region":"US","year":2022,"indication":"BCG-unresponsive high-risk NMIBC with CIS ± papillary tumours"},{"region":"EU","year":2026,"indication":"BCG-unresponsive NMIBC with CIS; 28 May 2026 (conditional)","note":"Conditional marketing authorisation"}],"mechanismSteps":["Instilled with Syn3 excipient to enhance transduction","Urothelial cells express and secrete IFN-α2b for weeks","Interferon induces apoptosis, anti-angiogenesis, and immune activation","Repeated every 3 months in responders"],"dosing":{"route":"Intravesical","schedule":"75 mL once every 3 months"},"toxicity":[{"event":"Fatigue","anyGradePct":24},{"event":"Bladder spasm","anyGradePct":20},{"event":"Micturition urgency","anyGradePct":19},{"event":"Grade 3+ treatment-related","grade3PlusPct":4}],"access":[],"regulatoryEvents":[]},"route":"/drugs/nadofaragene-firadenovec/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"non-muscle-invasive-bladder-cancer","kind":"cancer","name":"Non-muscle-invasive bladder cancer","route":"/cancers/non-muscle-invasive-bladder-cancer/"}],"technology":[{"id":"bcg-and-intravesical-therapy","kind":"technology","name":"Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)","route":"/technologies/bcg-and-intravesical-therapy/"},{"id":"oncolytic-virus","kind":"technology","name":"Oncolytic viruses","route":"/technologies/oncolytic-virus/"}],"company":[{"id":"ferring","kind":"company","name":"Ferring Pharmaceuticals","route":"/companies/ferring/"}],"term":[{"id":"bcg-unresponsive","kind":"term","name":"BCG-unresponsive","route":"/terms/bcg-unresponsive/"}],"trial":[{"id":"nct06545955","kind":"trial","name":"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","route":"/trials/nct06545955/"},{"id":"nct06510374","kind":"trial","name":"Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer","route":"/trials/nct06510374/"}],"idea":[{"id":"idea-bio2-oncolytic-regulated-il12","kind":"idea","name":"Oncolytic viruses that make interleukin-12 only inside the tumour","route":"/ideas/idea-bio2-oncolytic-regulated-il12/"}],"paper":[{"id":"paper-nadofaragene-firadenovec-lancet-oncol-2021","kind":"paper","name":"Nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer","route":"/key-papers/paper-nadofaragene-firadenovec-lancet-oncol-2021/"}],"drug":[{"id":"valrubicin","kind":"drug","name":"Valrubicin","route":"/drugs/valrubicin/"}],"roadmap":[{"id":"devices-roadmap","kind":"roadmap","name":"Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants","route":"/roadmaps/devices-roadmap/"}]}}