Gilead: Kite's CAR T-cell Therapy Yescarta Gets Positive Opinion From CHMP In EU

Gilead Sciences Inc. (GILD) announced Friday that its unit Kite's CAR T-cell Therapy Yescarta (axicabtagene ciloleucel) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP for use in second-line diffuse large B-cell lymphoma and high-grade B-cell lymphoma.

The positive opinion is for the use of Yescarta in adult patients with DLBCL and HGBL that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.

The CHMP's positive opinion is based on the primary results of the landmark Phase 3 ZUMA-7 study, the largest and longest trial of a CAR T-cell therapy versus standard of care (SOC) in second-line LBCL.

The European Commission will review the CHMP opinion, and a final decision on the marketing authorization is expected in the coming months.

If approved, Yescarta will be the first Chimeric Antigen Receptor or CAR T-cell therapy approved for patients in Europe who do not respond to first-line treatment.

Christi Shaw, CEO, Kite, said, "Today's positive CHMP opinion brings us a step closer to utilizing cell therapy earlier in the treatment journey, potentially transforming the standard of care for the most common and aggressive form of non-Hodgkin lymphoma."

ZUMA-7 is an ongoing, randomized, open-label, global, multicenter (US, Australia, Canada, Europe, Israel) 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.

Yescarta was first approved in Europe in 2018 and is currently indicated for three types of blood cancer: Diffuse Large B-Cell Lymphoma (DLBCL); Primary Mediastinal Large B-Cell Lymphoma (PMBCL); and Follicular Lymphoma (FL).

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