(Reuters) -The U.S. Food and Drug Administration approved ImmunityBio’s combination therapy to treat a type of bladder cancer, the regulator said on Monday, allowing the company’s first product to market.
The approval brings to an end the company’s years-long effort to market its cancer therapy. In May last year the FDA had declined clearance 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’s drug is used in combination with the Bacillus Calmette-Guérin (BCG) vaccine, which is mainly used against tuberculosis, but also used as a common treatment for some forms of bladder cancer.
The company did not immediately respond to a request seeking information on the therapy’s label, launch date and pricing.
(Reporting by Puyaan Singh and Pratik Jain in Bengaluru; Editing by Shailesh Kuber)
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