Gilead Sciences' (GILD) Kite said Friday that the U.S. Food and Drug Administration approved an update to the prescribing label for Yescarta, removing a prior limitation on use in patients with relapsed or refractory primary central nervous system lymphoma.
The change makes Yescarta the only CAR T-cell therapy for large B-cell lymphoma without this restriction, the company said. Primary CNS lymphoma is rare and aggressive, with a five-year survival rate of about 30%, and limited treatment options after relapse.
The FDA decision was based on a Phase 1 study led by Dana-Farber Cancer Institute, according to the company. In the study, most patients experienced neurologic side effects, but the safety profile supported use in this population, it said.