The Food and Drug Administration earlier this month approved Kite Pharma, Inc’s Yescarta for the treatment of “adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy,” according to the FDA.
FDA based its approval—the first for a CAR-T cell therapy for initial treatment of relapsed or refractory LBCL—on “a randomized, open-label, multicenter trial in adult patients,” Gilead’s press release said.
According to Gilead’s press release, the landmark “ZUMA-7 study demonstrated patients on Yescarta were 2.5 times more likely to be alive at two years without cancer progression or need for additional cancer treatment.”
“Definitive clinical trial results such as these do not come along often and should drive a paradigm shift in how patients with relapsed or refractory LBCL are treated moving forward,” said Jason Westin, a director of lymphoma clinical research at MD Anderson Cancer Center in Texas and principal investigator on the trial.
