Bladder cancer therapy, approved. Activates tumor-fighting cells

The US FDA on Monday approved ImmunityBio’s combination therapy to treat a type of bladder cancer, marking the end of the company’s efforts to bring its therapy to market. The agency’s green light is a boost for ImmunityBio, which expressed doubts in a regulatory filing last month about its ability to stay in business.

Last year, the US Food and Drug Administration (FDA) denied approval of the therapy, Anktiva, due to deficiencies found during a prelicensing inspection of the company’s contract manufacturing firms. The therapy works by activating types of disease-fighting white blood cells called natural killer (NK) cells and T cells to create long-term immunity in the body, Reuters reports.

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ImmunityBio said Anktiva will be available in US markets by mid-May 2024, but did not respond to a request for details on the therapy’s price tag. The medicine is used in combination with the Bacillus Calmette-Guérin (BCG) vaccine, which is mainly used against tuberculosis, but also as a common treatment for some forms of bladder cancer.

The purpose of the combination is to treat patients with a form of bladder cancer that does not respond to the vaccine and where the disease has not spread. This is found in about 75-85% of bladder cancer patients, the company said. Bladder cancer patients currently have to undergo a procedure called surgical ablation and receive either chemotherapy or the BCG vaccine as standard treatment. The past decade saw the approval of Merck’s Keytruda, but there is a risk of recurrence, said ImmunityBio executive chairman Patrick Soon-Shiong.

ImmunityBio aims to “generate long-term cancer-free survival,” Soon-Shiong added, adding that “the big goal is to advance cancer care beyond the recognition that you get a short-term response.” In a group of 83 patients in a late-phase study, the combination treatment showed complete disappearance of tumors in 71% of patients, with a median duration of response of 24.1 months.

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Bladder cancer – PHOTO: Freepik@WangXiNa

Bladder cancer, what is it

Bladder cancer is a condition in which abnormal cells begin to develop in the tissues of the bladder, the organ that stores urine before it is removed from the body. This type of cancer can occur in different parts of the bladder and can be of several types, including transitional cell carcinoma, squamous cell carcinoma, and adenocarcinoma.

Risk factors for bladder cancer include smoking, exposure to toxic chemicals (such as certain chemicals used in industry), bladder infections, and a family history of bladder cancer. Symptoms may include blood in the urine, frequent urination, and pain when urinating.

Diagnosing bladder cancer often involves tests such as cystoscopy (a procedure in which a doctor examines the inside of the bladder with a special instrument called a cystoscope) and biopsy (taking samples of tissue for examination under a microscope). Treatment depends on the stage of the cancer and may include surgery, radiation therapy, chemotherapy, and immunotherapy.

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