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{{Infobox drug | image = | width = | alt = | caption =  | gt_target_gene = [[Interferon alfa-2b]] | gt_vector = | gt_nucleic_acid_type = | gt_editing_method = | gt_delivery_method =  | pronounce = | tradename = Adstiladrin | Drugs.com = | MedlinePlus = a623062 | DailyMedID = Nadofaragene firadenovec | pregnancy_AU =  | pregnancy_AU_comment = | pregnancy_category = | routes_of_administration = [[Intravesical]] | class = | ATC_prefix = L01 | ATC_suffix = XL10 | ATC_supplemental =  | legal_AU =  | legal_AU_comment = | legal_BR =  | legal_BR_comment = | legal_CA =  | legal_CA_comment = | legal_DE =  | legal_DE_comment = | legal_NZ =  | legal_NZ_comment = | legal_UK =  | legal_UK_comment = | legal_US = Rx-only | legal_US_comment = <ref name="Adstiladrin FDA label">{{cite web | title=Adstiladrin- nadofaragene firadenovec-vncg suspension | website=DailyMed | date=30 October 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa | access-date=24 November 2024}}</ref><ref>{{cite web | title=Adstiladrin | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=16 December 2022 | url=https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/adstiladrin | access-date=16 December 2022 | id=STN: BLA 125700 | archive-date=17 December 2022 | archive-url=https://web.archive.org/web/20221217055104/https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/adstiladrin | url-status=live }}</ref> | legal_EU = | legal_EU_comment = | legal_UN =  | legal_UN_comment = | legal_status =   | bioavailability = | protein_bound = | metabolism = | metabolites = | onset = | elimination_half-life = | duration_of_action = | excretion =  | CAS_number = 1823059-12-6 | CAS_supplemental = | PubChemSubstance = 497620944 | IUPHAR_ligand = | DrugBank = DB17381 | ChemSpiderID = | UNII = 0OOS09O1FH | KEGG = D12531 | ChEBI = | ChEMBL = | NIAID_ChemDB = | PDB_ligand = | synonyms = Nadofaragene firadenovec-vncg, Instilidrin, rAd-IFN/Syn3  | IUPAC_name = | chemical_formula_ref = | chemical_formula = | C= | H= | Ag= | Al= | As= | Au= | B= | Bi= | Br= | Ca= | Cl= | Co= | F= | Fe= | Gd= | I= | K= | Li= | Mg= | Mn= | N= | Na= | O= | P= | Pt= | S= | Sb= | Se= | Sr= | Tc= | Zn= | charge= | molecular_weight = | molecular_weight_comment = | SMILES = | StdInChI = | StdInChI_comment = | StdInChIKey = | density = | density_notes = | melting_point = | melting_high = | melting_notes = | boiling_point = | boiling_notes = | solubility = | sol_units = | specific_rotation = }} '''Nadofaragene firadenovec''', sold under the brand name '''Adstiladrin''', is a [[gene therapy]] for the treatment of [[bladder cancer]].<ref name="Adstiladrin FDA label" /><ref name="FDA PR 20221216" /><ref name="FDA Adstiladrin" /> It is a non-replicating (cannot multiply in human cells) [[adenoviral]] vector-based gene therapy.<ref name="FDA PR 20221216">{{cite press release | title=FDA Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=16 December 2022 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treatment-high-risk-non-muscle-invasive-bladder-cancer | access-date=16 December 2022 | archive-date=16 December 2022 | archive-url=https://web.archive.org/web/20221216214436/https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treatment-high-risk-non-muscle-invasive-bladder-cancer | url-status=live }} {{PD-notice}}</ref> The most common adverse events including laboratory abnormalities, include increased glucose, instillation site discharge, increased triglycerides, fatigue, bladder spasm, micturition urgency, increased creatinine, hematuria, decreased phosphate, chills, dysuria, and pyrexia.<ref name="FDA Adstiladrin" /> Nadofaragene firadenovec was approved for medical use in the United States in December 2022.<ref name="FDA PR 20221216" /><ref name="FDA Adstiladrin">{{cite web | title=FDA approves first adenoviral vector-based gene therapy for high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer | website=U.S. [[Food and Drug Administration]] (FDA) | date=19 December 2022 | url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-first-adenoviral-vector-based-gene-therapy-high-risk-bacillus-calmette-guerin | access-date=19 December 2022 | archive-date=19 December 2022 | archive-url=https://web.archive.org/web/20221219203951/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-first-adenoviral-vector-based-gene-therapy-high-risk-bacillus-calmette-guerin | url-status=live }} {{PD-notice}}</ref><ref>{{cite press release | title=Ferring Receives Approval from U.S. FDA for Adstiladrin for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer | website=Ferring Pharmaceuticals USA | date=16 December 2022 | url=https://ferringusa.com/?press=ferring-receives-approval-from-u-s-fda-for-adstiladrin-for-high-risk-bcg-unresponsive-non-muscle-invasive-bladder-cancer | access-date=16 December 2022 | archive-date=17 December 2022 | archive-url=https://web.archive.org/web/20221217074455/https://ferringusa.com/?press=ferring-receives-approval-from-u-s-fda-for-adstiladrin-for-high-risk-bcg-unresponsive-non-muscle-invasive-bladder-cancer | url-status=live }}</ref> == Medical uses == Nadofaragene firadenovec is [[indicated]] for the treatment of adults with high-risk [[Bacillus Calmette-Guérin]] (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.<ref name="Adstiladrin FDA label" /><ref name="FDA PR 20221216" /> == History == The safety and effectiveness of nadofaragene firadenovec was evaluated in a multicenter clinical study (Study CS-003 (NCT02773849)) that included 157 participants with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer, 98 of whom had BCG-unresponsive carcinoma in situ with or without papillary tumors and could be evaluated for response.<ref name="FDA PR 20221216" /><ref name="FDA Adstiladrin" /> Participants received nadofaragene firadenovec once every three months for up to twelve months, or until unacceptable toxicity to therapy or recurrent high-grade non-muscle-invasive bladder cancer.<ref name="FDA PR 20221216" /><ref name="FDA Adstiladrin" /> Overall, 51% of enrolled participants using nadofaragene firadenovec therapy achieved a complete response (the disappearance of all signs of cancer as seen on cystoscopy, biopsied tissue, and urine).<ref name="FDA PR 20221216" /> The median duration of response was 9.7 months.<ref name="FDA PR 20221216" /> Forty-six percent of responding participants remained in complete response for at least one year.<ref name="FDA PR 20221216" /> The major efficacy outcome measures were complete response at any time and duration of response.<ref name="FDA Adstiladrin" /> Complete response was defined as negative cystoscopy with applicable transurethral resection of bladder tumor and biopsies and urine cytology.<ref name="FDA Adstiladrin" /> Random bladder biopsies of five sites were conducted in participants remaining in complete response at twelve months.<ref name="FDA Adstiladrin" /> The US [[Food and Drug Administration]] (FDA) granted the application for nadofaragene firadenovec [[priority review]], [[breakthrough therapy]], [[Fast track (FDA)|fast track]], and [[orphan drug]] designations.<ref name="FDA PR 20221216" /><ref name="FDA Adstiladrin" /> The FDA granted approval of Adstiladrin to [[Ferring Pharmaceuticals]] A/S.<ref name="FDA PR 20221216" /> == Society and culture == === Names === Nadofaragene firadenovec is the [[international nonproprietary name]] (INN).<ref name=WHORecList79>{{cite journal | vauthors = ((World Health Organization)) | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79 | journal = WHO Drug Information | volume = 32 | issue = 1 | year = 2018 | hdl = 10665/330941 | hdl-access = free | author-link = World Health Organization }}</ref> == References == {{reflist}} == External links == * {{ClinicalTrialsGov|NCT02773849|Adstiladrin (Instilidrin) in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)}} {{Chemotherapeutic agents}} {{Portal bar | Medicine}} {{DEFAULTSORT:Nadofaragene firadenovec}} [[Category:Cancer treatments]] [[Category:Drugs that are a gene therapy]] [[Category:Approved gene therapies]] [[Category:Orphan drugs]] {{Pharma-stub}} </textarea><div class="templatesUsed"><div class="mw-templatesUsedExplanation"><p><span id="templatesused">Pages transcluded onto the current version of this page<span class="posteditwindowhelplinks"> (<a href="/wiki/Help:Transclusion" title="Help:Transclusion">help</a>)</span>:</span> 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