FDA Approves Expanded Use of Gilead’s Yescarta

The U.S. FDA on April 1 approved Gilead’s axicabtagene ciloleucel, or yescarta, for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy, according to a statement from the regulator.

Key Excerpts

• Approval was based on ZUMA-7, a randomized, open-label, multicenter trial in adult patients with primary refractory LBCL or relapse within 12 months following completion of first-line therapy.
• It is not indicated for the treatment of patients with primary central nervous system lymphoma.

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Meghan Genovese in New York at mgenovese@bloomberg.net

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