Supplemental BLA filed with FDA for Yescarta in relapsed or refractory indolent non-Hodgkin lymphoma.- Kite Pharma/Gilead Sciences

Kite Pharma/Gilead Sciences have submitted a supplemental Biologics License Application (sBLA) to the FDA for Yescarta (axicabtagene ciloleucel) for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma - relapsed or refractory indolent non-Hodgkin lymphoma (NHL) - after two or more prior lines of systemic therapy. Yescarta was previously granted Breakthrough Therapy Designation by the FDA for these indications. If approved, Yescarta would become the first chimeric antigen receptor (CAR) T cell therapy approved for the treatment of relapsed or refractory indolent non-Hodgkin lymphoma (NHL). The sBLA submission is supported by data from the primary analysis of the Phase II ZUMA-5 trial, which is being submitted for presentation at an upcoming scientific congress. Findings from an interim analysis of ZUMA-5 were recently presented during an oral session at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting.Follicular lymphoma and marginal zone lymphoma are both forms of indolent non-Hodgkin lymphoma (NHL) in which malignant tumors slowly grow but can become more aggressive over time. Yescarta was the first CAR T cell therapy to be approved by the FDA 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 (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, and high grade B-cell lymphoma and DLBCL arising from FL.