Kite Reports sBLA Submission to the US FDA for Yescarta (axicabtagene ciloleucel) in Relapsed or Refractory Indolent Non-Hodgkin Lymphomas
Shots:
- The sBLA submission is based on an ongoing P-II ZUMA-5 study assessing single infusion of Yescarta in ~160 patients (≥18 yrs.) with r/r indolent NHL of either FL or marginal zone lymphoma subtypes- prior treated with 2L therapies- including an anti-CD20 mAb combined with an alkylating agent
- The 1EPs of the study is ORR as assessed by IRC while 2EPs include CRR- DOR- PFS- OS- safety and CAR T cell and cytokines levels
- Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy and has received the US FDA’s BT designation for indolent NHL. If approved- Yescarta would become the first CAR T cell therapy for this indication
Ref: Gilead | Image: Glassdoor
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