Kite’s Yescarta First CAR T-cell Therapy to Receive European Marketing Authorization for Use in Second-Line Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma
Kite, a Gilead Company (Nasdaq: GILD), today announces 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.
Diffuse large B-cell lymphoma (DLBCL) is the most common sub-type of non-Hodgkin lymphoma (NHL), representing around 30% of cases. High-grade B-cell lymphoma (HGBL) is a recently introduced, rare subset of LBCL marked by aggressive B-cell lymphomas. In Europe it is estimated that up to 38,000 new cases of LBCL were diagnosed in 2020.
Although first-line treatment can be effective in around 60% of cases, 40% will relapse or not respond and need second-line treatment.
Yescarta is now the first Chimeric Antigen Receptor (CAR) T-cell therapy 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.
ZUMA-7 is an ongoing, randomized, open-label, global, multicenter (US, Australia, Canada, Europe) Phase 3 study of 359 patients at 77 centers, evaluating the safety and efficacy of a single-infusion of Yescarta versus current SOC for second-line therapy in adult patients with relapsed or refractory LBCL within 12 months of first-line therapy.
Based on Landmark ZUMA-7 Study, Patients with DLBCL Treated Second-Line with Yescarta Had Event-Free Survival of 8.3 Months versus Two Months for SOC [4-fold greater improvement]
In ZUMA-7, Yescarta Patients with DLBCL were 2.5 Times More Likely than SOC to be Alive at Two Years Without Cancer Progression or Need for Additional Treatments.
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