EC Approves Kite’s Yescarta for Lymphoma

The European Commission has approved Gilead subsidiary Kite’s 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 first-line chemoimmunotherapy or are resistant to first-line therapy.

Yescarta is a chimeric antigen receptor (CAR) T-cell therapy, which uses the body’s own T cells to destroy cancer cells. The drug is the first CAR-T treatment approved in Europe for patients who do not respond to first-line treatment.

The approval was based on results from a phase 3 clinical trial, which showed that Yescarta-treated patients were four times as likely to have event-free survival over the current standard of care. The drug also showed a 2.5-fold increase in patients who were alive at two years without disease progression or the need for additional cancer treatment vs. the standard of care.

First approved in Europe in 2018, the therapy is also indicated for five types of blood cancer: diffuse large B-cell lymphoma, large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma.