Nogapendekin alfa inbakicept
Medication
From Wikipedia, the free encyclopedia
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]
| Combination of | |
|---|---|
| Nogapendekin alfa | human IL-15N72D variant |
| Inbakicept | interleukin-15 receptor agonist |
| Clinical data | |
| Trade names | Anktiva |
| Other names | ALT-803, N-803, nogapendekin alfa inbakicept-pmln |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a624034 |
| License data | |
| Routes of administration | Intravesical |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| PubChem SID | |
| KEGG | |
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
Legal status
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]
