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. 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. The US Food and Drug Administration considers it to be a first-in-class medication.

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.

Efficacy was evaluated in QUILT-3.032, 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. Participants received nogapendekin alfa inbakicept induction via intravesical instillation with BCG followed by maintenance therapy for up to 37 months. The US Food and Drug Administration granted the application for nogapendekin alfa inbakicept breakthrough therapy designation.

Nogapendekin alfa inbakicept was approved for medical use in the United States in April 2024.
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 to treat adults with a type of bladder cancer that affects the lining of the bladder and that is at high risk of growing and spreading. The applicant for this medicinal product is Serum Life Science Europe GmbH.