NEW YORK – The European Commission on Monday approved Gilead Sciences' Yescarta (axicabtagene ciloleucel) as a second-line treatment for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).
DLBCL and HGBL patients in Europe who relapse within one year of first-line chemotherapy or are refractory to it can now receive the autologous CAR T-cell therapy, a product of Gilead subsidiary Kite.
European regulators based their decision on the results of the Phase III ZUMA-7 study, in which 41 percent of patients on Yescarta didn't have disease progression or die after two years of follow-up versus 16 percent of patients on standard of care second-line therapy. Median event-free survival times with Yescarta versus standard of care were 8.3 months and 2 months, respectively.
The approval marks the first time a CAR T-cell therapy has been approved in the second-line treatment setting in Europe and follows the US Food and Drug Administration's approval in April. The FDA has also approved Bristol Myers Squibb's autologous CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) in the second-line lymphoma setting. BMS is further seeking second-line Breyanzi approval in Europe.