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FDA grants accelerated review for Novartis' Kymriah for treatment-resistant DLBCL

Published 01/17/2018, 06:49 AM
© Reuters.  FDA grants accelerated review for Novartis' Kymriah for treatment-resistant DLBCL
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  • The FDA grants Priority Review status for Novartis' (NYSE:NVS) CAR-T therapy Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant.
  • Priority Review status shortens the review clock to six month from the standard 10 months.
  • Kymriah was first approved in the U.S. in August 2017 for B-cell acute lymphoblastic leukemia.
  • Previously: Novartis submits U.S. marketing application for expanded use of Kymriah (Oct. 31, 2017)
  • Now read: Upcoming Conversation With An Expert: Highlights In CAR-T


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