Yescarta Receives European Marketing Authorization for Treatment of Relapsed or Refractory DLBCL and PMBC

August 28, 2018

Kite has announced that the European Commission (EC) has granted Marketing Authorization for Yescarta (axicabtagene ciloleucel) as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. The Marketing Authorization approves the treatment for use in the 28 European Union countries and Norway, Iceland, and Liechtenstein.   Axicabtagene ciloleucel is a chimeric antigen receptor T cell (CAR T) therapy, which harnesses a patient’s own immune system to fight certain types of blood cancer. The cell therapy has been proven to induce complete response (no detectable cancer) in a proportion of patients with relapsed or refractory DLBCL and PMBCL, which are aggressive forms of non-Hodgkin lymphoma.   “Axicabtagene ciloleucel is a new and exciting way of treating cancer that offers a new option to patients with DLBCL and PMBCL in Europe,” said Professor Gilles Salles, Head of Hematology, South Lyon Hospital Complex. “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.”   Axicabtagene ciloleucel was approved by FDA on October 18, 2017.    See Pharm Exec’s report on Yescarta in its 2018 Brands of the Year.