FDA grants regulatory approval to Kite's Yescarta
Kite, a Gilead company, announced that the U.S. Food and Drug Administration has granted regular approval to Yescarta, the first chimeric antigen receptor T cell herapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma transformed follicular lymphoma, or TFLvous system lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. CAR T therapy is a breakthrough in hematologic cancer treatment in which a patient's own T cells are engineered to seek and destroy cancer cells. CAR T therapy is manufactured specifically for each individual patient. Yescarta has a Boxed Warning in its product label regarding the risks of cytokine release syndrome and neurologic toxicities. A Risk Evaluation and Mitigation Strategy has been approved by the FDA for Yescarta. The REMS program will inform and educate healthcare professionals about the risks associated with Yescarta therapy. Training and certification on the REMS program will be an integral part of the final authorization for centers offering Yescarta. The list price of Yescarta in the United States is $373,000.