Pharmaceutical compound
| 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 |
| 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. It is an interleukin-15 receptor agonist. It is given in combination with Bacillus Calmette-Guérin via intravesical drug delivery. It contains nogapendekin alfa, a human IL-15N72D variant; and inbakicept, an interleukin 15 receptor subunit alpha.
The most common adverse reactions include increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.
Nogapendekin alfa inbakicept was approved for medical use in the United States in April 2024.
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.
History
Efficacy was evaluated in QUILT-3.032 (NCT0302285), a single-arm, multicenter trial of 77 participants with Bacillus Calmette-Guérin-unresponsive, high-risk non-muscle invasive bladder cancer with carcinoma in situ with or without Ta/T1 papillary disease following transurethral resection. Participants received nogapendekin alfa inbakicept induction via intravesical instillation with Bacillus Calmette-Guérin followed by maintenance therapy for up to 37 months. The US Food and Drug Administration (FDA) granted the application for nogapendekin alfa inbakicept breakthrough therapy designation.
References
- ^ "Anktiva- nogapendekin alfa inbakicept-pmln solution". DailyMed. 9 May 2024. Retrieved 18 May 2024.
- "Nogapendekin Alfa (Code C107503)". NCI Thesaurus. 25 March 2024. Archived from the original on 30 April 2024. Retrieved 25 April 2024.
- World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.
- "Inbakicept (Code C177093)". NCI Thesaurus. 25 March 2024. Archived from the original on 30 April 2024. Retrieved 25 April 2024.
- World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information. 33 (3). hdl:10665/330879.
- ^ "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.
- "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 29 April 2024. Archived from the original on 30 April 2024. Retrieved 30 April 2024.
- "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.
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.
External links
- 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
