FDA Approves Shorter Manufacturing Process for CAR T-cell Therapy Axicabtagene Ciloleucel

The FDA approved a new manufacturing process that will shorten the median turnaround time (TAT) of axicabtagene ciloleucel(Yescarta; Kite) from 16 days to 14 days. Reducing the time it takes to manufacture this chimeric antigen receptor T (CAR T)-cell therapy can speed up delivery time to a patient to boost their chance of survival, explained Cindy Perettie, executive vice president of Kite, in a press release.

“For patients with relapsed or refractory [R/R] large B-cell lymphoma [LBCL], every day matters as the patient’s disease can be aggressive and worsen rapidly,” said Perettie in the press release.

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Axicabtagene ciloleucel is a CD19-directed genetically modified autologous CAR T-cell immunotherapy. CAR T-cell therapies are manufactured by using the patient’s own white blood cells (T-cells), which are removed through leukapheresis. The patient’s T-cells are then sent to the manufacturing facility, where they are modified with a chimeric antigen receptor. The cells are then checked, preserved, packed, and sent back to the hospital for infusion with the patient.

Since patients get an individualized treatment with CAR T-cell therapy, it is important to ensure that each treatment is one of quality and timeliness, explained Chris McDonald, SVP, global head of technical operations at Kite, in the press release.

“Time is a critical factor in cell therapy, and it can make the difference between a patient being able to receive CAR T or their cancer progressing to the point where they are no longer strong enough for treatment,” said David Miklos, MD, PhD, a clinical investigator at Kite and the chief of Blood and Marrow Transplant and Cell Therapy at Stanford University, in the press release. “Therefore, optimizing steps in the process and ultimately reducing the time to CAR T-cell therapy infusion is paramount.”

Kite has more than 135 authorized treatment centers in the United States. CAR T-cell therapies have been administered to more than 17,700 patients at treatment centers. Some of the most common adverse events (AEs) associated with axicabtagene ciloleucel include neurological toxicities (eg, encephalogpathy, headache, and tremors), gastrointestinal issues, CRS, and immune issues (eg, fever, chills, cough, and infection with an unspecified pathogen).

This therapy is currently indicated for the treatment of adult patients with R/R LBCL following 1 line of chemoimmunotherapy, R/R disease following 2 or more lines of systemic therapy or R/R follicular lymphoma (FL) following 2 or more lines of prior systemic therapy.

“[Axicabtagene ciloleucel] is the first and only treatment to demonstrate superior overall survival over the standard of care as a second-line treatment with curative intent for these patients, and today’s decision by the FDA allows us to further shorten our delivery time of [axicabtagene ciloleucel] so that patients have the best possible chance of survival,” Perettie said in the press release.

REFERENCE

Kite Receives U.S. FDA Approval of Manufacturing Process Change Resulting in Reduced Median Turnaround Time for Yescarta® CAR T-cell Therapy. Kite. News Release. January 30, 2024. Accessed on January 31, 2024. https://www.businesswire.com/news/home/20240121113292/en