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
- 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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