Anktiva FDA Approval History
Last updated by Judith Stewart, BPharm on April 24, 2024.
FDA Approved: Yes (First approved April 22, 2024)
Brand name: Anktiva
Generic name: nogapendekin alfa inbakicept-pmln
Previous Name: N-803
Company: ImmunityBio, Inc.
Treatment for: Bladder Cancer
Anktiva (nogapendekin alfa inbakicept-pmln) is a first-in-class interleukin-15 superagonist for use in combination with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma.
- BCG is an effective bladder cancer treatment for many patients, but it doesn’t work for an estimated 40% of non-muscle-invasive bladder cancer carcinoma (NMIBC) cases. Anktiva is intended to treat BCG-unresponsive NMIBC to avoid radical cystectomy (removal) of the bladder.
- Interleukin-15 (IL-15) is a cytokine that plays a crucial role in the immune system by affecting the development, maintenance, and function of natural killer (NK) and CD8+ killer T cells. Anktiva is an IL-15 superagonist complex that works by binding to IL-15 receptors on NK, CD4, and CD8 T cells to drive the generation of memory killer T cells that have specifically been trained to recognize the cancer cells.
- In a multicenter trial of 77 patients who received received Anktiva with BCG maintenance therapy for up to 37 months, 62% (95% CI, 51-73) of the patients achieved a complete response. The duration of complete response ranged from 0-47 months (ongoing) and was ≥ 12 months in 58% of patients and ≥ 24 months in 40% of patients.
- Anktiva is administered intravesically (directly into the bladder through a catheter) with BCG once a week for 6 weeks (induction) then once a week for 3 weeks at months 4, 7, 10, 13 and 19 (maintenance). A second induction course may be administered if complete response is not achieved at month 3. For patients with an ongoing complete response at month 25 and later, additional maintenance instillations with BCG may be administered once a week for 3 weeks at months 25, 31, and 37. The Anktiva and BCG admixture should be retained in the bladder for 2 hours and then voided.
- Warnings and precautions associated with Anktiva include the possibility of the development of metastatic bladder cancer by delaying cystectomy, and embryo-fetal toxicity. Females of reproductive potential should use effective contraception during treatment, and for one week after the last dose.
- Common (≥15%) adverse reactions include dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, musculoskeletal pain, chills and pyrexia. Common laboratory test abnormalities include increased creatinine and increased potassium.
Development timeline for Anktiva
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
