Primary analysis of ZUMA-5 trial of Yescarta (axicabtagene ciloleucel) shows high response rates in indolent non-Hodgkin lymphoma
In study (n=104), 92% of patients responded after a single infusion, including 76% achieving a complete response at a median follow-up of 17.5 months. Based on these data, the FDA has accepted the supplemental Biologics License Application and granted Priority Review designation.
Source:
Biospace Inc.
SPS commentary:
The submission in US is for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines of systemic therapy.
In UK, Yescarta is currently only licensed for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma, after two or more lines of systemic therapy.