Europe Approves First CAR T-Cell Therapy For B-Cell Lymphoma In 30 Years to Improve Upon Standard of Care

The European Commission approved Kite Pharma's, a Gilead Sciences Inc GILD Yescarta (axicabtagene ciloleucel) for diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).
The approval covers patients who relapse within 12 months of completion or are refractory to first-line chemoimmunotherapy.
The approval is based on results from the pivotal Phase 3 ZUMA-7 study, the largest and longest trial of a CAR T-cell therapy versus SOC in this patient population.
Also Read: MacroGenics Shares Jump On Gilead Licensing Pact For Blood Cancer Candidates.
Yescarta is now the first Chimeric Antigen Receptor (CAR) T-cell therapy approved for European patients who do not respond to first-line treatment.
The ZUMA-7 study demonstrated that at a median follow-up of two years, Yescarta-treated patients had a four-fold greater improvement in the primary endpoint of event-free survival over the current SOC.
Additionally, Yescarta demonstrated a 2.5-fold increase in patients alive at two years without disease progression or needing additional cancer treatment vs. SOC (41% v 16%).
Price Action: GILD shares are up 0.20% at $66.51 during the premarket session on the last check Tuesday.