Chemistry:Nogapendekin alfa inbakicept

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Short description: Medication

Nogapendekin alfa inbakicept
Combination of
Nogapendekin alfahuman IL-15N72D variant
Inbakiceptinterleukin-15 receptor agonist
Clinical data
Trade namesAnktiva
Other namesALT-803, N-803, nogapendekin alfa inbakicept-pmln
AHFS/Drugs.comMonograph
MedlinePlusa624034
License data
Routes of
administration		Intravesical
ATC code
Legal status
Legal status
Identifiers
PubChem SID
KEGG

Nogapendekin alfa inbakicept, sold under the brand name Anktiva, is a fixed-dose combination medication used for the treatment of bladder cancer.[1] It is an interleukin-15 receptor agonist.[1] It is given in combination with Bacillus Calmette-Guérin (BCG) via intravesical drug delivery.[1] It contains nogapendekin alfa, a human IL-15(N72D) variant, which is more potent than regular IL-15;[4][5] and inbakicept, an interleukin 15 receptor subunit alpha agonist.[6][7]

The most common adverse reactions include increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.[8]

Nogapendekin alfa inbakicept was approved for medical use in the United States in April 2024.[8] The US Food and Drug Administration considers it to be a first-in-class medication.[9]

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.[1][8]

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.[8] Participants received nogapendekin alfa inbakicept induction via intravesical instillation with BCG followed by maintenance therapy for up to 37 months.[8] The US Food and Drug Administration (FDA) granted the application for nogapendekin alfa inbakicept breakthrough therapy designation.[8]

Society and culture

Nogapendekin alfa inbakicept was approved for medical use in the United States in April 2024.[8][10]

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).[2] The applicant for this medicinal product is Serum Life Science Europe GmbH.[2][11] Nogapendekin alfa inbakicept was authoried for medical use in the European Union in February 2026.[2][3]

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 "Anktiva- nogapendekin alfa inbakicept-pmln solution". 9 May 2024. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eae31db8-3e7a-d9e0-708d-74419d1b50ff. 
  2. ↑ 2.0 2.1 2.2 2.3 "Anktiva EPAR". 12 December 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/anktiva.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  3. ↑ 3.0 3.1 "Anktiva PI". 17 February 2026. https://ec.europa.eu/health/documents/community-register/html/h2002.htm. 
  4. ↑ "Nogapendekin Alfa (Code C107503)". 25 March 2024. https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C107503. 
  5. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information 34 (1). 2020. 
  6. ↑ "Inbakicept (Code C177093)". 25 March 2024. https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C177093. 
  7. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information 33 (3). 2019. 
  8. ↑ 8.0 8.1 8.2 8.3 8.4 8.5 8.6 "FDA approves nogapendekin alfa inbakicept-pmln for bladder cancer". 22 April 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle-invasive-bladder-cancer.  Public Domain This article incorporates text from this source, which is in the public domain.
  9. ↑ (PDF) New Drug Therapy Approvals 2024 (Report). January 2025. https://www.fda.gov/media/184967/download. Retrieved 21 January 2025. 
  10. ↑ "ImmunityBio Announces FDA Approval of Anktiva, First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer" (Press release). ImmunityBio. 23 April 2024. Archived from the original on 23 April 2024. Retrieved 24 April 2024 – via Business Wire.
  11. ↑ "New medicine to treat non-muscle invasive bladder cancer". 12 December 2025. https://www.ema.europa.eu/en/news/new-medicine-treat-non-muscle-invasive-bladder-cancer.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

Further reading

  • Clinical trial number NCT0302285 for "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" at ClinicalTrials.gov



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