U.S. FDA Approves ANKTIVA for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

ImmunityBio, Inc. today announced that the U.S. Food and Drug Administration (FDA) had approved ANKTIVA® (N-803) plus Bacillus Calmette-Guérin (BCG) vaccine for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

This treatment is essential as bladder cancer is the 10th most commonly diagnosed cancer globally, and the American Cancer Society estimates there will be 83,190 new cases and 16,840 deaths from bladder cancer in the U.S. in 2024.

"The FDA's approval of ANKTIVA marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on April 22, 2024.

"ANKTIVA not only proliferates and activates the patient's own NK cells and CD8+ killer T cells, but also activates CD4+ T helper cells, thus enhancing the proliferation of memory killer T cells. 

ANKTIVA is a novel IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4, and CD8 T cells.

ANKTIVA is expected to be available in the United States by mid-May 2024, as well as ImmunityBio's Patient Assistance Program.

Merck's TICE® BCG vaccine is used in this therapy.