September 4, 2020 -- Kite, a Gilead company, has submitted a supplemental biologics license application (sBLA) to the U.S. Food and Drug Administration (FDA) for axicabtagene ciloleucel (Yescarta) for the treatment of relapsed or refractory follicular lymphoma or marginal zone lymphomas after two or more prior therapies.
The CD19-directed genetically modified autologous T-cell immunotherapy was previously granted a breakthrough therapy designation (BTD) by the FDA for these indications. It was the first chimeric antigen receptor (CAR) T-cell therapy approved for the treatment of relapsed or refractory large B-cell lymphoma. If approved, the drug will become the first CAR T therapy approved for the treatment of relapsed or refractory indolent non-Hodgkin lymphoma.
The sBLA filing is supported by data from the primary analysis of a phase II ZUMA-5 trial. Findings were presented in an oral session at the 2020 American Society of Clinical Oncology (ASCO) annual meeting.
Follicular lymphoma is the most common form of indolent lymphoma and the second most common type of lymphoma globally. It accounts for approximately 22% of all lymphomas diagnosed worldwide. Marginal zone lymphoma is the third most common lymphoma, accounting for 8% to 12% of all B-cell non-Hodgkin lymphomas. There are currently no standard-of-care treatments for these relapsed or refractory lymphomas.