• Date: April 22, 2024
  • Company: ImmunityBio
  • Brand: Anktiva
  • Generic: nogapendekin alfa inbakicept-pmln
  • Indication: treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

On April 22, 2024, the US Food and Drug Administration (FDA) approved ImmunityBio’s first-in-class interleukin-15 superagonist (IL-15) nogapendekin alfa inbakicept-pmln (Anktiva), plus bacillus Calmette-Guérin (BCG), for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. 

Designated an FDA Breakthrough Therapy, the novel immunotherapy ANKTIVA activates the body’s natural killer (NK) and killer T-cell immune system to attack tumor cells. ANKTIVA is expected to be available in the U.S. by mid-May 2024  

With the recent approval of Anktiva, we will be looking at possible updates to the following clinical practice guidelines in the coming months and years:

  1. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer (AUA/SUO)
  2. Urothelial Cancer (SITC)
  3. Immunotherapy for the Treatment of Urothelial Cancer (Update) (SITC)
  4. Immunotherapy for the Treatment of Bladder Cancer (SITC)
  5. Bladder Cancer (NCCN)

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