Kite files for new Yescarta indication in USA

US biotech major Gilead Sciences’ (Nasdaq: GILD) subsidiary Kite today announced that it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration for Yescarta (axicabtagene ciloleucel) for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines of systemic therapy.

Yescarta was previously granted Breakthrough Therapy designation (BTD) 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.