Bladder Cancer Therapy by ImmunityBio gets FDA Approval

Health regulators in the United States on Monday approved ImmunityBio’s combination therapy for the treatment of a type of bladder cancer. This effectively ends the company’s long effort to bring its therapy to the market.

Getting the approval was paramount to ImmunityBio’s survival in the market. Last month, the company expressed doubts about its continued existence in a regulatory filing. The United States Food and Drug Administration (FDA) declined to greenlight the therapy, Anktiva, last year after it found deficiencies during a pre-license inspection of the company’s contract manufacturing firms. 

ImmunityBio’s therapy works by activating T-cells and natural killer (NK) cells (types of disease-fighting white blood cells) to create long-term immunity in the body. ImmunityBio has given a mid-2024 timeline to bring Anktiva to the United States markets but has yet to reveal how much the therapy would cost.

ImmunityBio’s Anktiva is a combination therapy

Anktiva is used in combination with the Bacillus Calmette-Guerin (BCG) vaccine, a popular shot against tuberculosis, which has also been found to be effective against some forms of bladder cancer. 

The combination aims to treat patients suffering from a form of bladder cancer that is unresponsive to the vaccine where the disease is not disseminated. This type of bladder cancer is seen in around 75 to 85% of patients, according to ImmunityBio.

The current treatment for bladder cancer involves a procedure called surgical ablation which is followed by BCG or chemotherapy as a standard treatment. Previous bladder cancer therapy approved by the FDA in the last decade was Merck’s Keytruda. However, ImmunityBio’s executive chairman Patrick Soon-Shiong said there was a chance of recurrence after its use.

According to Soon-Shiong, ImmunityBio plans to “generate cancer-free long-term overall survival,” adding that “the big goal is to advance cancer care beyond just recognizing you get a short-term response”.

In a late-stage study of Anktiva involving 83 patients, the combination treatment recorded a total disappearance of tumors in 71% of patients, with a median response duration of 24.1 months.