Nogapendekin alfa inbakicept
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 via intravesical drug delivery.[1] 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.[6] Nogapendekin alfa inbakicept was approved for medical use in the United States in April 2024.[1][6][7][8] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[9] Medical usesNogapendekin 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] HistoryEfficacy 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.[6] Participants received nogapendekin alfa inbakicept induction via intravesical instillation with Bacillus Calmette-Guérin 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] References
Further reading
External links
|
Portal di Ensiklopedia Dunia