US FDA approves ImmunityBio's bladder cancer therapy

Food and Drug Administration (FDA) headquarters in White Oak, Maryland

By Puyaan Singh and Pratik Jain

(Reuters) -The U.S. health regulator approved on Monday ImmunityBio's combination therapy to treat a type of bladder cancer, marking an end to the company's efforts to bring its therapy to the market.

The agency's green light is a shot in the arm for ImmunityBio, which had reiterated doubts in a regulatory filing last month about its ability to remain in business.

Last year, the U.S. Food and Drug Administration (FDA) declined clearance for the therapy, Anktiva, over deficiencies found during pre-license 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.

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

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 forms of bladder cancer.

The combination aims to treat patients with a form of bladder cancer, which is unresponsive to the vaccine and in which the disease has not spread. This is seen in about 75-85% patients of bladder cancer, the company said.

Bladder cancer patients currently have to undergo a procedure called surgical ablation and either get chemotherapy or BCG vaccine as a standard treatment.

The last decade has seen the approval of Merck's Keytruda, but there is a chance of recurrence, said ImmunityBio's executive chairman Patrick Soon-Shiong.

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

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

(Reporting by Puyaan Singh and Pratik Jain in Bengaluru; Additional reporting by Mrinmay Dey; Editing by Shailesh Kuber and Sherry Jacob-Phillips)