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FDA lifts use restriction for Kite's Yescarta in primary CNS lymphoma

The FDA has removed previous use restrictions for Yescarta (axicabtagene ciloleucel) from Kite in relapsed or refractory primary central nervous system lymphoma. The updated prescribing information allows use of the CAR‑T therapy in appropriate patients; the decision is based on an investigator‑initiated phase 1 study from the Dana‑Farber Cancer Institute. In the study, 85% of patients experienced neurologic toxicities, 31% were grade 3 events; Yescarta remains labeled with a boxed warning for cytokine release syndrome, neurologic toxicities, and secondary hematologic malignancies. Primary CNS lymphoma has a poor prognosis and until now many patients had very limited treatment options. » Plus sur de.investing.com