Kymriah and Yescarta approved in the EU

Novartis’ chimeric antigen receptor T cell therapy Kymriah (tisagenlecleucel) has been approved in the EU for treating paediatric and young adults up to the age of 25 with B-cell acute lymphoblastic leukemia that is refractory, in relapse post-transplant or in second or later relapse. It has also been approve for treating adults with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.

Gilead’s CAR-T therapy Yescarta (axicabtagene ciloleucel) has received approval in the EU for diffuse large B-cell lymphoma and for primary mediastinal large B-cell lymphoma, after two or more lines of systemic therapy.

Both therapies are being assessed by NICE for use on the NHS in England, and Simon Stevens, NHS England chief executive, said they need to be available at an affordable price for all those requiring treatment.

Professor Gilles Salles, head of Hematology, South Lyon Hospital Complex, said: “Kymriah is a new and exciting way of treating cancer that offers a new option to patients with DLBCL and PMBCL in Europe. Many patients with these aggressive forms of non-Hodgkin lymphoma who have not responded to or failed commonly available treatment options have a very poor prognosis and there is an urgent need for new therapies.”