CAR-T Follicular Lymphoma Approval Yescarta(Axicabtagene Ciloleucel)

CAR-T Follicular Lymphoma Approval Yescarta(Axicabtagene Ciloleucel)

– In October 18, 2017, the FDA approved Yescarta(Axicabtagene Ciloleucel), a CAR T-cell therapy, for the treatment of relapsed or refractory follicular lymphoma in adults after two or more prior lines of systemic therapy.

– This is the first FDA-approved CAR T-cell therapy for follicular lymphoma, which is a slow-growing form of non-Hodgkin lymphoma.

– Brexucabtagene autoleucel is a one-time treatment that uses a patient’s own genetically modified T-cells to recognize and kill lymphoma cells that express the CD19 protein.

– The approval was based on results from the ZUMA-5 clinical trial, which showed an overall response rate of 92% in follicular lymphoma patients treated with this CAR T-cell therapy.

– Common side effects included cytokine release syndrome, neurological toxicities, and low blood cell counts. A boxed warning was included regarding these toxicities.

– This approval provides a new targeted immunotherapy option for follicular lymphoma patients whose cancer has progressed after multiple prior treatments.

– Brexucabtagene autoleucel was jointly developed by Kite Pharma and Gilead Sciences based on research from the National Cancer Institute.

Let me know if you need any additional details on this new CAR T-cell therapy approval for relapsed/refractory follicular lymphoma.