The United States Food and Drug Administration (USFDA) on Monday announced that it has approved ImmunityBio’s combination therapy to treat a type of bladder cancer.
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, as per a report by news agency PTI.
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, as per PTI.
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, as quoted by PTI, 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.
