Kite’s manufacturing plant in El Segundo, California, will supply Europe with the newly approved CAR-T therapy Yescarta while a facility in The Netherlands is being prepared.

Gilead Sciences has received marketing authorization from the European Commission (EC) for its chimeric antigen receptor T (CAR-T) cell therapy Yescarta (axicabtagene ciloleucel). The therapy is approved to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL).

Yescarta production: From the US to Europe, for now. Image: iStock/Cunaplus_M.Faba

“Across the European Union, it is estimated that in 2018 there will be approximately 7,700 patients with DLBCL who are refractory to initial treatment or who have relapsed after multiple lines of therapy, and may be eligible for CAR T therapy,” Gilead spokesperson Sarah Swift told BioProcess Insider.

Gilead entered the CAR-T space last August through the US$11.9 billion (€10 billion) acquisition of Kite Pharma, several weeks before Yescarta became only the second CAR-T cell therapy to receive US Food and Drug Administration (FDA) approval. The first was Novartis’ Kymriah (tisagenlecleucel), which has also been approved in Europe.

California to Amsterdam

Yescarta is made by isolating peripheral blood mononuclear cells, including T-cells, from a patient’s own white blood cells. These are sent to one of Gilead/Kite’s manufacturing facilities where they are stimulated to proliferate and combined with a retroviral vector, propagated in cell culture bags, before being infused back into the patient at a clinical center.

For European supply, Swift said Yescarta will initially be US-made, produced at Kite’s dedicated manufacturing facility in El Segundo, California. The 43,500 ft2 plant has capacity to treat up to 5,000 patients a year.

For personalized medicines it is somewhat crucial to ensure there is a reliable cold-chain supply network in place as the patient is part of the supply chain. Swift did not divulge the logistics strategy in how Gilead will ensure Yescarta reaches European patients from California but did confirm EU supply will eventually be made locally.

Earlier this year, Kite/Gilead leased a new facility in the Netherlands to engineer cell therapies in Europe. The plant will take over supply once it is fully operational in 2020.

“The location of Hoofddorp (near SEGRO Park Amsterdam Airport) was chosen due to its central European location and favourable transport links which will enable personalized cell therapies to be consistently manufactured in state-of-the-art facilities while in close geographic proximity to the patients who will receive them,” said Swift.