欧州医薬品庁(EMA)が、CAR-T療法であるtisagenlecleucel (Kymriah)とaxicabtagene ciloleucel (Yescarta)について、EUにおける承認を勧告【ESMO】

EMA Recommends Granting Marketing Authorisations for the First Two CAR T-cell Therapies in the EU

On 28 June 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisations for the first two chimeric antigen receptors (CAR) T-cell therapies in the European Union. Tisagenlecleucel (Kymriah) and ciloleucel (Yescarta) are both advanced therapy medicinal products (ATMPs). Kymriah is intended for the treatment of relapsed or refractory acute lymphoblastic leukaemia (ALL) and relapsed or refractory diffuse large B-cell lymphoma (DLBCL), while Yescarta is intended for treatment of relapsed or refractory DLBCL and relapsed or refractory primary mediastinal B-cell lymphoma (PMBCL).

 

 

 

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