Gilead's CAR-T therapy Yescarta gets European approval for second-line treatment of lymphoma
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Gilead's (NASDAQ:GILD) firm Kite said on Monday the European Commission had approved its (CAR) T-cell therapy, Yescarta, to treat adult patients with diffuse large B-cell lymphoma and high-grade B-cell lymphoma, who relapsed within 12 months from completion of first-line chemoimmunotherapy.

Yescarta becomes the first CAR-T therapy in Europe for second-line treatment of lymphoma.
The approval is based on results from a Phase 3 trial, dubbed ZUMA-7, which showed that patients with diffuse large B-cell lymphoma treated Second-Line with Yescarta Had event-free survival of 8.3 months versus two months for standard of care.
The study also showed that patients treated with Yescarta were 2.5 times more likely than standard of care to be alive at two years without cancer progression or need for additional treatments.
Yescarta was first approved in Europe in 2018 and is currently 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.
Yescarta was approved in 2017 in the U.S. for patients with large B-cell lymphoma who did not respond to at least two previous rounds of therapy.