By Pooyan Singh and Pratik Jain

London: The US health regulator approved on Monday immunitybio’S combination therapy The company’s efforts to bring its therapy to market, to treat a type of bladder cancer, came to an end.

The agency’s green light is a blow to ImmunityBio, which reiterated doubts about its ability to stay in business in a regulatory filing last month.

Last year, the US Food and Drug Administration had denied approval for the therapy, Unctiva, due to deficiencies found during pre-license inspections of the company’s contract manufacturing companies.

The therapy works by activating disease-fighting white blood cells called natural killer (NK) cells. T cells To create long-term immunity in the body.

The company did not immediately respond to a request seeking details on the therapy’s label, availability and pricing.

ImmunityBio’s drug is used in combination with the Bacillus Calmette-Guerin (BCG) vaccine, which is used primarily against tuberculosis but also as a common treatment for some forms of bladder cancer. goes.

The combination is intended to treat patients with a form of bladder cancer that does not respond to the vaccine and in whom the disease has not spread. This is seen in approximately 75-85 percent of bladder cancer patients, the company said.

Bladder cancer patients currently have to undergo a procedure called surgical ablation and either receive chemotherapy bcg vaccine As a standard treatment.

Patrick Soon-Shiong, executive chairman of ImmunityBio, said Merck’s Keytruda has gained approval over the past decade, but there is a potential for relapse.

ImmunityBio’s goal is “to generate cancer-free long-term overall survival,” Soon-Shiong said, adding, “The bigger goal is to advance cancer care beyond recognizing that you get a short-term response.”

In the 83-patient arm of the late-stage study, the combination treatment caused tumors to completely disappear in 71 percent of patients, with a median duration of response of 24.1 months. (Reporting by Puyan Singh and Pratik Jain in Bengaluru; Editing by Shailesh Kuber)