China-based Fosun Kite Biotechnology Co., Ltd, a joint venture (JV) between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) and Gilead subsidiary Kite Pharma, has revealed that Yescarta (axicabtagene ciloleucel) has obtained priority review status for adult large B-cell lymphoma (r/r LBCL) that is refractory to first-line immunochemotherapy or has relapsed within 12 months of first-line immunochemotherapy. This marks a significant milestone in the development and potential market availability of the therapy.
Clinical Trial and Regulatory Milestones
Yescarta, an anti-CD19 chimeric antigen receptor (CAR) T therapy, was approved for clinical trials for the same indication in August this year. The therapy has already been approved in the US and Europe to treat lymphoma in October 2017 and August 2018, respectively. In the same month this year, Yescarta also received clinical trial approval for second-line and above relapsed or refractory indolent non-Hodgkin lymphoma (r/r iNHL) after systemic therapy in China. Additionally, the therapy obtained breakthrough therapy designation (BTD) status for that indication in August this year.
Future Outlook
The priority review status for Yescarta underscores Fosun Kite’s commitment to advancing innovative treatments for patients with refractory large B-cell lymphoma. With multiple regulatory milestones achieved, Yescarta is poised to potentially transform the treatment landscape for these challenging cancers.-Fineline Info & Tech
