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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 ends the company's struggles to bring the drug to the market.

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Ayanna Amadi
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Bladder Cancer Therapy by ImmunityBio gets FDA Approval

Bladder Cancer Therapy by ImmunityBio gets FDA Approval

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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.

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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

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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. 

Cancer Natural Killer Bladder Cancer Bacillus Calmette-Guerin
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