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Kite Receives EMA approval for CAR-T Cell therapy manufacturing facility in Europe


Kite has received approval to implement a variation to the Yescarta Marketing Authorization from the European Medicine Agency (EMA) for end-to-end manufacturing. With this approval, Kite’s European manufacturing facility, designed and dedicated to the manufacture of individualized cell therapies, is now fully operational.

Time-lapse video of the construction of Kite’s cell therapy manufacturing facility located outside of Amsterdam.

“Kite is focused foremost on the needs of patients living with cancer and we are proud to now manufacture cell therapy directly in Europe,” said Christi Shaw, Chief Executive Officer of Kite. “This facility will benefit both patients and healthcare professionals, allowing Yescarta to reach European treatment centers more quickly and reducing the time it takes to reach patients by almost a week.”

Kite has nearly 90 qualified treatment centers in 16 countries across Europe and Israel. The new European facility sits next to one of Europe’s largest airports, Amsterdam Airport Schiphol. This central location, with its transport links to the region, will reduce the delivery time to and from treatment centers. The facility has the capacity to produce therapy for up to 4,000 patients per year.

“With the enhanced technology and processes at our new facility we are pleased to be leading the next chapter in the manufacture and delivery of CAR T therapy,” said Charles Calderaro, Kite’s Global Head of Technical Operations. “Our new European manufacturing facility is dedicated to cutting-edge cell engineering, enabling patients to receive their potentially life-saving treatment more quickly.”

“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.”

Source: Kite (press release)