A monumental achievement for ImmunityBio, Inc., occurred earlier this week, leaving the door open for potential major benefits to the Dunkirk community.

Earlier this week, the Food and Drug Administration officially approved ANKTIVA, a treatment for unresponsive non-muscle invasive bladder cancer. ANKTIVA is expected to be available in the U.S. by the middle of May.

“The FDA’s approval of ANKTIVA marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio.

The development is a major step for ImmunityBio, who has recently taken over the former Athenex plant off Route 5 in Dunkirk. ImmunityBio began leasing the property in February 2022, with major layoffs to employees upon its arrival.

ImmunityBio’s 2022 year-end report to the SEC stated, “In September 2022, we initiated a workforce reduction at the Dunkirk facility as a result of upcoming construction at the project, which we believe may take approximately 12 to 18 months. We believe this facility will provide us with a state-of-the-art biotech production center that will substantially expand and diversify our existing manufacturing capacity in the U.S. and the ability to scale production across all of our key platforms.”

ANKTIVA received Breakthrough Therapy Designation and approval from the FDA based on the safety and efficacy outcome of complete responses and duration of complete responses throughout trials that evaluated 77 patients. The patients received ANKTIVA with Bacillus Calmette-Guérin (BCG) treatments for up to 37 months. The status of tumors evaluated were assessed with cystoscopy and urine cytology and will continue for up to five years after each patient began their participation in the trial.