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BRIEF-FDA approves first gene therapy available in the United States
August 30, 2017 / 3:04 PM / 22 days ago

BRIEF-FDA approves first gene therapy available in the United States

Aug 30 (Reuters) - U.S. Food and Drug Administration:

* Says approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia ‍​

* Also expanded approval of Actemra (tocilizumab) to treat CAR T-cell-induced severe or life-threatening CRS in patients 2 yrs of age/older‍​

* Says granted approval of Kymriah to Novartis Pharmaceuticals Corp and granted the expanded approval of Actemra to Genentech Inc‍​

* Treatment with Kymriah has the potential to cause severe side effects, it carries a boxed warning for cytokine release syndrome (CRS) Source text: (bit.ly/2grlPdB) Further company coverage:

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