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EU approves first CAR-T therapies

European regulators have approved Novartis’ Kymriah and Gilead’s Yescarta, enabling patients to access CAR-T therapies across the region for the first time.
Kymriah (tisagenlecleucel) has been cleared for the treatment of paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Yescarta (axicabtagene ciloleucel) was also approved for DLBCL and also for primary mediastinal large B-cell lymphoma, after two or more lines of systemic therapy.
Both chimeric antigen receptor T cell (CAR T) therapies work by harnessing a patient’s own immune system to fight certain types of blood cancer. During the process, T cells are drawn from a patient’s blood and reprogrammed in the lab to create T cells that are genetically coded to hunt the patient’s cancer cells.
“Bringing Kymriah to patients in the EU advances the treatment paradigm in an unprecedented way and delivers a lifesaving therapy to young patients with ALL who have not been successfully treated with existing therapies, and who have limited options left,” said Prof. Peter Bader, head of the Division for Stem Cell Transplantation and Immunology and principal investigator of the ELIANA study at the University Hospital for Children and Adolescents in Frankfurt/Main.
Commenting on the approval of Yescarta, Professor Gilles Salles, head of Hematology, South Lyon Hospital Complex, said the therapy offers “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.”
Earlier this year, NHS England chief executive Simon Stevens indicated that the NHS was preparing for the introduction of CAR-T this year, offering eligible patients a ‘ground-breaking’ approach to treating cancer. But he also stressed manufacturers “need to set fair and affordable prices so treatments can be made available to all who need them.”
Yescarta and Kymriah are currently being assessed by the National Institute for Health and Care Excellence (NICE) for use on the NHS in England. A final decision on both drugs is expected by late 2018, though the Institute has just released a draft decision rejecting funding for Yescarta.