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EMA's CHMP Recommends Gilead's Yescarta for Second-Line Lymphoma

NEW YORK – The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended approval for Gilead Sciences' Yescarta (axicabtagene ciloleucel) as a second-line treatment for diffuse large B-cell lymphoma and high-grade B-cell lymphoma patients.

The committee is recommending the CAR T-cell therapy based on results from the Phase III Zuma-7 study, in which 41 percent of patients on Yescarta were alive without disease progression or death after two years versus 16 percent of patients who received standard of care second-line therapy.

CHMP specified that the recommendation applies to high-grade B-cell lymphoma patients whose cancers relapse within a year of first-line chemo-immunotherapy. If the European Commission approves the treatment based on the committee's recommendation, Yescarta will be the first CAR T-cell therapy approved in the second-line setting in Europe.

The recommendation follows the US Food and Drug Administration's approval of Yescarta as a second-line option for large B-cell lymphoma patients in April. In June, the FDA also approved a competing autologous CAR T-cell therapy — Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) — in the same setting. BMS has also submitted an application to the EMA seeking second-line approval for Breyanzi.