{{Short description|Medication}} {{Use American English|date=April 2024}} {{Use dmy dates|date=April 2024}} {{cs1 config |name-list-style=vanc |display-authors=6}} {{Infobox drug | type = combo | image = | width = | alt = | caption =
<!-- Combo data --> | component1 = Nogapendekin alfa | class1 = human IL-15N72D variant | component2 = Inbakicept | class2 = interleukin-15 receptor agonist
<!-- Clinical data --> | tradename = Anktiva | Drugs.com = {{drugs.com|monograph|nogapendekin-alfa-inbakicept-pmln}} | MedlinePlus = a624034 | DailyMedID = Nogapendekin alfa inbakicept | pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> | pregnancy_AU_comment = | pregnancy_category = | routes_of_administration = Intravesical | ATC_prefix = L03 | ATC_suffix = AC03 | ATC_supplemental = | biosimilars =
<!-- Legal status --> | legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled --> | legal_AU_comment = | legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F --> | legal_BR_comment = | legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII --> | legal_CA_comment = | legal_DE = <!-- Anlage I, II, III or Unscheduled --> | legal_DE_comment = | legal_NZ = <!-- Class A, B, C --> | legal_NZ_comment = | legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C --> | legal_UK_comment = | legal_US = Rx-only | legal_US_comment = <ref name="Anktiva FDA label">{{cite web | title=Anktiva- nogapendekin alfa inbakicept-pmln solution | website=DailyMed | date=9 May 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eae31db8-3e7a-d9e0-708d-74419d1b50ff | access-date=18 May 2024}}</ref> | legal_EU = | legal_EU_comment = | legal_UN = <!-- N I, II, III, IV / P I, II, III, IV --> | legal_UN_comment = | legal_status = <!-- For countries not listed above -->
<!-- Identifiers --> | CAS_number = | CAS_supplemental = | PubChemSubstance = 497621301 | IUPHAR_ligand = | DrugBank = | ChemSpiderID = | UNII = | KEGG = D12888 | ChEBI = | ChEMBL = | NIAID_ChemDB = | PDB_ligand = | synonyms = ALT-803, N-803, nogapendekin alfa inbakicept-pmln }}
'''Nogapendekin alfa inbakicept''', sold under the brand name '''Anktiva''', is a fixed-dose combination medication used for the treatment of bladder cancer.<ref name="Anktiva FDA label" /> It is an interleukin-15 receptor agonist.<ref name="Anktiva FDA label" /> It is given in combination with Bacillus Calmette-Guérin (BCG) via intravesical drug delivery.<ref name="Anktiva FDA label" /> It contains nogapendekin alfa, a human IL-15(N72D) variant, which is more potent than regular IL-15;<ref>{{cite web | title=Nogapendekin Alfa (Code C107503) | website=NCI Thesaurus | date=25 March 2024 | url=https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C107503 | access-date=25 April 2024 | archive-date=30 April 2024 | archive-url=https://web.archive.org/web/20240430023859/https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C107503 | url-status=live }}</ref><ref>{{cite journal | year = 2020 | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83 | journal = WHO Drug Information | volume = 34 | issue = 1 | hdl = 10665/339768 | hdl-access = free }}</ref> and inbakicept, an interleukin 15 receptor subunit alpha agonist.<ref>{{cite web | title=Inbakicept (Code C177093) | website=NCI Thesaurus | date=25 March 2024 | url=https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C177093 | access-date=25 April 2024 | archive-date=30 April 2024 | archive-url=https://web.archive.org/web/20240430024043/https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C177093 | url-status=live }}</ref><ref>{{cite journal | year = 2019 | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82 | journal = WHO Drug Information | volume = 33 | issue = 3 | hdl = 10665/330879 | hdl-access = free }}</ref>
The most common adverse reactions include increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.<ref name="FDA 20240422">{{cite web |date=22 April 2024 |title=FDA approves nogapendekin alfa inbakicept-pmln for bladder cancer |url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle-invasive-bladder-cancer |url-status=live |archive-url=https://web.archive.org/web/20240430023857/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle-invasive-bladder-cancer |archive-date=30 April 2024 |access-date=24 April 2024 |website=U.S. Food and Drug Administration}} {{PD-notice}}</ref>
Nogapendekin alfa inbakicept was approved for medical use in the United States in April 2024.<ref name="FDA 20240422" /> The US Food and Drug Administration considers it to be a first-in-class medication.<ref>{{cite report | title=New Drug Therapy Approvals 2024 | website=U.S. Food and Drug Administration (FDA) | date=January 2025 | url=https://www.fda.gov/media/184967/download | format=PDF | access-date=21 January 2025 | archive-url=https://web.archive.org/web/20250121045744/https://www.fda.gov/media/184967/download | archive-date=21 January 2025 | url-status=live }}</ref>
== Medical uses == Nogapendekin alfa inbakicept is indicated with Bacillus Calmette-Guérin for adults with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma ''in situ'' with or without papillary tumors.<ref name="Anktiva FDA label" /><ref name="FDA 20240422" />
== History == Efficacy was evaluated in QUILT-3.032 (NCT0302285), a single-arm, multicenter trial of 77 participants with BCG-unresponsive, high-risk non-muscle invasive bladder cancer with carcinoma ''in situ'' with or without Ta/T1 papillary disease following transurethral resection.<ref name="FDA 20240422" /> Participants received nogapendekin alfa inbakicept induction via intravesical instillation with BCG followed by maintenance therapy for up to 37 months.<ref name="FDA 20240422" /> The US Food and Drug Administration (FDA) granted the application for nogapendekin alfa inbakicept breakthrough therapy designation.<ref name="FDA 20240422" />
== Society and culture == === Legal status === Nogapendekin alfa inbakicept was approved for medical use in the United States in April 2024.<ref name="FDA 20240422" /><ref>{{cite press release |title=ImmunityBio Announces FDA Approval of Anktiva, First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer |date=23 April 2024 |publisher=ImmunityBio |url=https://www.businesswire.com/news/home/20240422820209/en/ |via=Business Wire |access-date=24 April 2024 |url-status=live |archive-url=https://web.archive.org/web/20240423223956/https://www.businesswire.com/news/home/20240422820209/en |archive-date=23 April 2024}}</ref>
In December 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Anktiva (nogapendekin alfa inbakicept) to treat adults with a type of bladder cancer that affects the lining of the bladder (non-muscle invasive bladder cancer) and that is at high risk of growing and spreading (carcinoma in situ, with or without papillary tumors).<ref name="Anktiva EPAR" /> The applicant for this medicinal product is Serum Life Science Europe GmbH.<ref name="Anktiva EPAR">{{cite web | title=Anktiva EPAR | website=European Medicines Agency (EMA) | date=12 December 2025 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/anktiva | access-date=22 December 2025}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref>{{cite web | title=New medicine to treat non-muscle invasive bladder cancer | website=European Medicines Agency (EMA) | date=12 December 2025 | url=https://www.ema.europa.eu/en/news/new-medicine-treat-non-muscle-invasive-bladder-cancer | access-date=22 December 2025}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>
== References == {{reflist}}
== Further reading == * {{cite journal | vauthors = Chamie K, Chang SS, Kramolowsky E, Gonzalgo ML, Agarwal PK, Bassett JC, Bjurlin M, Cher ML, Clark W, Cowan BE, David R, Goldfischer E, Guru K, Jalkut MW, Kaffenberger SD, Kaminetsky J, Katz AE, Koo AS, Sexton WJ, Tikhonenkov SN, Trabulsi EJ, Trainer AF, Spilman P, Huang M, Bhar P, Taha SA, Sender L, Reddy S, Soon-Shiong P | title = IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer | journal = NEJM Evidence | volume = 2 | issue = 1 | article-number = EVIDoa2200167 | date = January 2023 | pmid = 38320011 | doi = 10.1056/EVIDoa2200167 }}
== External links == * {{ClinicalTrialsGov|NCT0302285|QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer}}
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Category:Bladder cancer Category:Combination drugs