The United States Food and Drug Administration (USFDA) 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.

Last year, the US Food and Drug Administration (FDA) declined clearance for the therapy, Anktiva, over deficiencies found during the pre-license inspection of the company’s contract manufacturing firms.

“We are pleased that treatment with ANKTIVA now exceeds the clinically meaningful benchmarks established by the IBCG in 2016 for durable complete response,” said Roger Buckley, with the IBCG.

“We look forward to the global availability of ANKTIVA to potentially reduce the need for cystectomy in many patients worldwide with NMIBC,” he commented.

The duration of response is ongoing, so the final median duration of response has yet to be determined. Fifty-eight percent of patients with CR had a DOR ≥ 12 months and 40 percent had a DOR ≥ 24 months.

“The long duration of complete response ranging over 47 months is a game changer for NMIBC patients and provides further clinical evidence of ANKTIVA’s effectiveness for patients who historically have faced high rates of recurrence and significantly diminished quality of life due to radical surgeries,” said Karim Chamie, MD, Associate Professor of Urology at UCLA and principal investigator for the QUILT 3.032 study.

“With this approval, ANKTIVA could represent a new standard of care for patients with NMIBC and has the potential to change the way we treat bladder cancer,” Chamie added.

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.

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 percent patients of bladder cancer, the company said.

Bladder cancer patients currently have to undergo a procedure called surgical ablation and either get chemotherapy or the 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.