Kite’s Yescarta First CAR T-cell Therapy to Receive European Marketing Authorization for Use in 2nd Line B-cell Lymphoma
Kite, a Gilead Company has announced that the European Commission (EC) has granted approval for the use of Yescarta® (axicabtagene ciloleucel) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
The approval is based on results from the pivotal Phase 3 ZUMA-7 study which is the largest and longest trial of a CAR T-cell therapy versus SOC in this patient population. Yescarta is now the first CAR T-cell therapy that has been approved for patients in Europe – who do not respond to first-line treatment. This provides an important additional treatment option for the most common form of non-Hodgkin lymphoma. Although 60% of newly diagnosed LBCL patients, including those with DLBCL, will respond to their initial treatment, 40% will relapse or will not respond and need second-line treatment.
Professor John Gribben, Professor of Medical Oncology at the Cancer Research UK Barts Centre, London has said that “This approval marks a major shift in the treatment of LBCL when initial treatment has failed. In ZUMA-7, treatment with axicabtagene ciloleucel resulted in an overall better outcome for patients than standard of care, especially in terms of event-free survival, marking a new era for treatment earlier in the disease pathway for more patients”.
Yescarta was first approved in Europe in 2018 and is currently indicated for five types of blood cancer: Diffuse Large B-Cell Lymphoma (DLBCL); Large B-Cell Lymphoma (LBCL); High-Grade B-Cell Lymphoma (HGBL); Primary Mediastinal Large B-Cell Lymphoma (PMBCL); and Follicular Lymphoma (FL).
Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kite’s singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company.