Kite Receives EMA Approval for CAR T Cell Facility in Europe

Kite (Santa Monica, CA), a Gilead company, has announced it has received approval to implement a variation to the Yescarta® (axicabtagene ciloleucel) Marketing Authorization from the European Medicines Agency (EMA) for end-to-end manufacturing. With this approval, the company reports, Kite’s European manufacturing facility, designed and dedicated to the manufacture of individualized cell therapies, is now fully operational.    The European facility is located next to Amsterdam Airport Schiphol (The Netherlands) and has the capacity to produce therapy for up to 4,000 patients per year. Kite invested €130 million ($150 million) over just two years to transform the 19,000 square meter site, which employs over 300 people.    Christi Shaw, Chief Executive Officer of Kite, said the facility “will benefit both patients and healthcare professionals, allowing axicabtagene ciloleucel to reach European treatment centres more quickly and reducing the time it takes to reach patients by almost a week.”    Marie José Kersten, M.D., Ph.D., of Amsterdam University Medical Centers, added, “Timely access to cell therapy is critical, and the ability to manufacture CAR T cell therapies in Europe is welcomed by the clinical community.”