The new FDA-approved manufacturing process for Kite’s CAR-T cell therapy Yescarta will allow a 14-day turnaround compared to 16 days, the company announced on Tuesday.
Pictured: Artist’s rendering of cell therapy concept/iStock, Meletios Verras
Gilead Sciences’ Kite Pharma received FDA approval for a faster manufacturing process for its CAR-T cell therapy, according to an announcement on Tuesday. Kite said that its manufacturing of Yescarta (axicabtagene ciloleucel) will now bring its median turnaround time from 16 to 14 days.
According to Kite, the median turnaround time is from when a patient’s T cells are collected to the product being released, with the production of that medicine being a critical step to get the medicine into the patient.
“For patients with relapsed or refractory large B-cell lymphoma, every day matters as the patient’s disease can be aggressive and worsen rapidly,” Cindy Perettie, Kite’s executive vice president, said in a statement. “Yescarta 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 Yescarta so that patients have the best possible chance of survival.”
Because CAR-T cell therapies are one-time use and come from a patient’s body, the process can take time to be turned into a finished product. The manufacturing process is also continuous and the scheduling and manufacturing are “critical” for keeping up supply, according to Kite.
“Given that each cell therapy batch is unique to each patient, manufacturing is central to how we deliver our therapies, and quality, reliability, and speed are critical,” Chris McDonald, global head of technical operations at Kite, said in a statement.”
While there is a broader interest in CAR T therapies, the medicine has also come under scrutiny from the FDA. Following a safety probe, the agency earlier this month asked all makers of approved CAR T therapies, including Kite and Gilead, to put a class-wide box warning about the potential risk of T-cell malignancies on their products.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
