Nogapendekin alfa inbakicept

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;[2][3] and inbakicept, an interleukin 15 receptor subunit alpha agonist.[4][5]

The most common adverse reactions include increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.[6]

Nogapendekin alfa inbakicept was approved for medical use in the United States in April 2024.[6] The US Food and Drug Administration considers it to be a first-in-class medication.[7]

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][6]

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.[6] Participants received nogapendekin alfa inbakicept induction via intravesical instillation with BCG followed by maintenance therapy for up to 37 months.[6] The US Food and Drug Administration (FDA) granted the application for nogapendekin alfa inbakicept breakthrough therapy designation.[6]

Society and culture

Nogapendekin alfa inbakicept was approved for medical use in the United States in April 2024.[6][8]

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).[9] The applicant for this medicinal product is Serum Life Science Europe GmbH.[9][10]

References

  1. ^ a b c d e "Anktiva- nogapendekin alfa inbakicept-pmln solution". DailyMed. 9 May 2024. Retrieved 18 May 2024.
  2. ^ "Nogapendekin Alfa (Code C107503)". NCI Thesaurus. 25 March 2024. Archived from the original on 30 April 2024. Retrieved 25 April 2024.
  3. ^ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). 2020. hdl:10665/339768.
  4. ^ "Inbakicept (Code C177093)". NCI Thesaurus. 25 March 2024. Archived from the original on 30 April 2024. Retrieved 25 April 2024.
  5. ^ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information. 33 (3). 2019. hdl:10665/330879.
  6. ^ a b c d e f g "FDA approves nogapendekin alfa inbakicept-pmln for bladder cancer". U.S. Food and Drug Administration. 22 April 2024. Archived from the original on 30 April 2024. Retrieved 24 April 2024. This article incorporates text from this source, which is in the public domain.
  7. ^ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.
  8. ^ "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.
  9. ^ a b "Anktiva EPAR". European Medicines Agency (EMA). 12 December 2025. Retrieved 22 December 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  10. ^ "New medicine to treat non-muscle invasive bladder cancer". European Medicines Agency (EMA). 12 December 2025. Retrieved 22 December 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

Further reading

  • Chamie K, Chang SS, Kramolowsky E, Gonzalgo ML, Agarwal PK, Bassett JC, et al. (January 2023). "IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer". NEJM Evidence. 2 (1) EVIDoa2200167. doi:10.1056/EVIDoa2200167. PMID 38320011.
  • 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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