Kite has received approval for the manufacture of Yescarta (axicabtagene ciloleucel) from its manufacturing facility based in Amsterdam, the Netherlands. The company received marketing authorization from the European Medicines Agency for end-to-end manufacturing from the location.
As a result, the facility is now fully operational and able to produce Yescarta, a chimeric antigen receptor (CAR)-T therapy, for up to 4,000 patients per year in Europe.
The treatment is approved for adult patients with relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma.
Christi Shaw, CEO of Kite, said, “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.”
When BioPharma-Reporter spoke to Dominique Tonelli, head of medical affairs, Europe, for Kite, she explained how the previous process for delivering the treatment in the region was complicated and added delays.
Before the European facility’s approval, the treatment had to be manufactured in Los Angeles, US, after cells were taken from patients in Europe, before then returning to Europe. At the time, she told us that its Amsterdam facility could reduce delivery of the treatment by at least three or four days.
Manufacturing network buildout
The official operational status of Kite’s Amsterdam facility sees it expand outside of its current US base. The company posses commercial manufacturing facilities in El Segundo, California, and clinical manufacturing facilities in Santa Monica, California, and Gaithersburg, Maryland.
Beyond this, Kite is also building a third commercial cell therapy, also in Maryland, which will be used to provide additional capacity for the CAR-T therapy.
In addition, another facility, being constructed by parent company, Gilead within one its existing facilities, will be added to its network to produce viral vectors in Oceanside, California.
In terms of why the company is investing so much into its manufacturing capacity, Gilead CEO, Daniel O’Day previously stated that it would provide a competitive advantage by reducing turnaround time for cell therapies.
Direct rival in the CAR-T space, Novartis, has already suffered manufacturing setbacks in its commercialization of its own product, Kymriah (tisagenlecleucel).