Kite Reports sBLA Submission to the US FDA for Yescarta (axicabtagene ciloleucel) in Relapsed or Refractory Indolent Non-Hodgkin Lymphomas

 Kite Reports sBLA Submission to the US FDA for Yescarta (axicabtagene ciloleucel) in Relapsed or Refractory Indolent Non-Hodgkin Lymphomas

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

Click here ­to­ read full press release/ article | Ref: Gilead | Image: Glassdoor

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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