The EMA has given the therapy priority medicine designation for KTE-X19, second CAR-T from Gilead Sciences’ Kite Pharma subsidiary, allowing for an expedited review of the dossier and setting up a possible approval before year-end. Kite has filed for approval of the new CAR-T in mantle cell lymphoma (MCL) on the strength of impressive data from the ZUMA-2 trial – reported at last year’s American Society of Haematology (ASH) meeting – patients in relapsed or refractory MCL. If approved, KTE-X19 will become the first CAR-T therapy for this indication, according to Kite, which also submitted it to the FDA last month. The therapy has also been granted breakthrough status by the US agency, allowing for a potential six-month review of data.