BRIEF—EMA nod for Kite's for CAR T Cell therapy facility in Europe

Kite, a part of Gilead Sciences, today announced it has received approval to implement a variation to the Yescarta (axicabtagene ciloleucel) Marketing Authorization from the European Medicine Agency 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.

Christi Shaw, Chief Executive Officer of Kite, commented: “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.”

Yescarta was approved in the European Union in 2018 as a treatment for 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.

Yescarta, which generated sales of $456 million in full-year 2019 and $140 million in the first quarter of this year, is also approved by the US Food and Drug Administration.