The US FDA approves ImmunityBio’s bladder cancer therapy

The U.S. health regulator on Monday approved ImmunityBio’s combination therapy to treat a form of bladder cancer, ending the company’s efforts to commercialize its therapy.

The agency’s green light is a shot in the arm for ImmunityBio, which had again raised doubts about its ability to stay in business in a regulatory filing last month.

Last year, the U.S. Food and Drug Administration (FDA) denied approval for the therapy, Anktiva, due to deficiencies found during pre-licensure inspections at the company’s contract manufacturing facilities.

The therapy works by activating types of disease-fighting white blood cells, natural killer (NK) cells and T cells, to create long-lasting immunity in the body.

ImmunityBio said Anktiva will be available in U.S. markets in mid-May 2024, but did not respond to a request for details on the therapy’s label price.

The drug 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 types of bladder cancer.

The combination aims 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 seen in approximately 75-85% of patients with bladder cancer, the company said.

Bladder cancer patients currently must undergo a procedure called surgical ablation and receive standard chemotherapy or a BCG vaccine.

Merck’s Keytruda has been approved for the past decade, but there is a chance of a recurrence, said Patrick Soon-Shiong, executive chairman of ImmunityBio.

ImmunityBio’s goal is “to generate long-term cancer-free overall survival,” Soon-Shiong said, adding that “the big goal is to advance cancer care beyond just recognizing that you’re getting a short-term response .”

In an 83-patient arm of a late-stage trial, the combination treatment demonstrated complete tumor disappearance in 71% of patients, with a median duration of response of 24.1 months.