The FDA has approved the CD19-directed CAR T-cell therapy axicabtagene ciloleucel (axi-cel; Yescarta) as a treatment for adults with relapsed or refractory non-Hodgkin lymphoma (NHL), based on complete remission (CR) rates in the phase II ZUMA-1 trial.
The CAR T-cell therapy was approved with a boxed warning regarding CRS. To address the risk of CRS and neurologic toxicities, the FDA approved axi-cel with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). Additionally, certification and training will be required before hospitals will be cleared to administer the T cell therapy. The required training will focus on identifying and managing CRS and neurologic toxicity.
"It is important to note that the toxicities that we saw—CRS and neurological events—are generally reversible," lead investigator Frederick L. Locke, MD, medical oncologist at Moffitt Cancer Center, told OncLive at the 2017 AACR Annual Meeting. "These are going away within 1 month of the therapy, so we think that this is a therapy that can be safely administered across multiple centers for patients who are really without other treatment options."
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