Nogapendekin alfa inbakicept explained
| Type: | combo |
| Component1: | Nogapendekin alfa |
| Class1: | human IL-15N72D variant |
| Component2: | Inbakicept |
| Class2: | interleukin-15 receptor agonist |
| Tradename: | Anktiva |
| Dailymedid: | Nogapendekin alfa inbakicept |
| Routes Of Administration: | Intravesical |
| Atc Prefix: | None |
| Legal Us: | Rx-only |
| Legal Us Comment: | [1] |
| Pubchemsubstance: | 497621301 |
| Kegg: | D12888 |
| 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. 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;[2] [3] and inbakicept, an interleukin 15 receptor subunit alpha.[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.
Nogapendekin alfa inbakicept was approved for medical use in the United States in April 2024.[6] [7] [8]
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.
Further reading
- 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 . IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer . NEJM Evidence . 2 . 1 . EVIDoa2200167 . January 2023 . 38320011 . 10.1056/EVIDoa2200167 .
Notes and References
- Web site: Anktiva- nogapendekin alfa inbakicept-pmln solution . DailyMed . 9 May 2024 . 18 May 2024.
- Web site: Nogapendekin Alfa (Code C107503) . NCI Thesaurus . 25 March 2024 . 25 April 2024 . 30 April 2024 . https://web.archive.org/web/20240430023859/https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C107503 . live .
- ((World Health Organization)) . 2020 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83 . WHO Drug Information . 34 . 1 . 10665/339768 . free . World Health Organization .
- Web site: Inbakicept (Code C177093) . NCI Thesaurus . 25 March 2024 . 25 April 2024 . 30 April 2024 . https://web.archive.org/web/20240430024043/https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C177093 . live .
- ((World Health Organization)) . 2019 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82 . WHO Drug Information . 33 . 3 . 10665/330879 . free . World Health Organization .
- Web site: FDA approves nogapendekin alfa inbakicept-pmln for bladder cancer . U.S. Food and Drug Administration . 22 April 2024 . 24 April 2024 . 30 April 2024 . 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 . live .
- Web site: Novel Drug Approvals for 2024 . U.S. Food and Drug Administration (FDA) . 29 April 2024 . 30 April 2024 . 30 April 2024 . https://web.archive.org/web/20240430031024/https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024 . live .
- ImmunityBio Announces FDA Approval of Anktiva, First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer . ImmunityBio . Business Wire . 23 April 2024 . 24 April 2024 . 23 April 2024 . https://web.archive.org/web/20240423223956/https://www.businesswire.com/news/home/20240422820209/en . live .
