Kite, a Gilead Company, has announced that the European Commission (EC) has granted Marketing Authorisation 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 Authorisation approves axicabtagene ciloleucel for use in the 28 countries of the European Union, 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 (NHL).
“Many patients with these aggressive forms of non-Hodgkin lymphoma have a very poor prognosis and there is an urgent need for new therapies.”
The Marketing Authorisation Application (MAA) is supported by data from the ZUMA-1 trial of axicabtagene ciloleucel in adult patients with refractory aggressive NHL.
In the single-arm trial, 72 percent of patients who received a single infusion of axicabtagene ciloleucel responded to therapy, with 51 percent achieving a complete response. At one year following infusion, 60 percent of patients were alive and the median overall survival (OS) had not been reached.
Yescarta may cause side effects that are severe or life threatening, such as Cytokine Release Syndrome (CRS) or Neurological Toxicities. In ZUMA-1, 12 percent of patients experienced Grade 3 or higher CRS and 31 percent experienced Grade 3 or higher neurologic toxicities. Overall 98 percent of patients recovered from CRS and/or neurologic adverse reactions.
Alessandro Riva, MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy said, “We are proud to be leading this frontier of cancer innovation that is bringing novel, personalised therapy to people living with these blood cancers. Our vision is for cell therapy to serve as the foundation for treating all cancer types. Today’s important milestone is another important step on this exciting and important journey.”
Professor Gilles Salles, Head of Hematology, South Lyon Hospital Complex said, “Axicabtagene ciloleucel 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.”