Kite receives approval for CAR T cell therapy manufacturing in Europe
Kite, which is part of research-based biopharmaceutical company Gilead Sciences, announced it has received approval to implement a variation to the Yescarta (axicabtagene ciloleucel) Marketing Authorisation from the European Medicines Agency (EMA) for end-to-end manufacturing at its facility located in Amsterdam, The Netherlands.
With this approval, Kite said that its European manufacturing facility, designed and dedicated to the manufacture of individualised cell therapies, is now fully operational. “Kite is focussed foremost on the needs of patients living with cancer and we are proud to now manufacture cell therapy directly in Europe”, said Christi Shaw, CEO, Kite. “This 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.”
Presently, Kite has nearly 90 qualified treatment centres in 16 countries across Europe and Israel. The company’s Amsterdam facility is located close to the Schiphol airport, with multiple transport links to the region and enabling the delivery time to and from treatment centres to be reduced. According to Kite, it has the capacity to produce therapy for up to 4,000 patients each year, and the company has invested €130 million over just two years to transform the 19,000 sq m site, which employs over 300 people. “With the technology and processes at our facility we are pleased to be leading the next chapter in the manufacture and delivery of CAR T cell therapy”, said Charles Calderaro, Global Head of Technical Operations, Kite. “The prognosis for patients with refractory large B-cell lymphoma is poor, with a median survival of approximately six months with the prior standard of care”, said Marie José Kersten, MD, PhD, Amsterdam University Medical Centers, Amsterdam, the Netherlands. “Timely access to cell therapy is critical, and the ability to manufacture CAR T cell therapies in Europe is welcomed by the clinical community.”
Headquartered in in Santa Monica, California, Kite is engaged in the development of innovative cancer immunotherapies, with a focus on chimeric antigen receptor and T cell receptor engineered cell therapies. In August 2018, axicabtagene ciloleucel (Yescarta), a CAR T cell therapy, received Marketing Authorisation in the EU for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.