FDA Approves Gene Therapy for Certain Types of Non-Hodgkin Lymphoma
The Food and Drug Administration (FDA) has approved Yescarta (axicabtagene ciloleucel; Kite Pharma) for the treatment of adults with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least 2 other kinds of treatment. This is the second chimeric antigen receptor (CAR) T cell therapy approved by the FDA following Kymriah (tisagenlecleucel; Novartis) in August 2017.
Yescarta, a CD19-directed genetically modified autologous T cell immunotherapy, is indicated for use in large B-cell lymphoma including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. It is not indicated to treat patients with primary central nervous system lymphoma.
The safety and efficacy of Yescarta were evaluated in a multicenter trial involving >100 adults with refractory or relapsed large B-cell lymphoma. The data indicated a 51% complete remission rate following treatment with Yescarta.
Doses of Yescarta are individually tailored based on the patient's immune system to fight the lymphoma. The patient's T cells are obtained and genetically altered to incorporate a new gene that kills the cancer cells. The modified cells are then infused back into the patient.
Yescarta carries a Boxed Warning regarding cytokine release syndrome (CRS) and neurologic toxicities; both adverse events may be fatal. Other adverse events include serious infections, low blood cell counts, and a weakened immune system. Yescarta is being approved with a risk evaluation and mitigation strategy (REMS) to assure safe use of the treatment. Hospitals and related clinics must be certified, and staff involved in prescribing, dispensing or administering Yescarta require training.
Yescarta will be available as a cell suspension for infusion containing 2×106 CAR-positive viable T cells per kg of body weight, with a maximum of 2×108 CAR-positive viable T cells in approximately 68mL.
For more information call (844) 454-5483 or visit Yescarta.com.