Posted by Michael Wonder on 30 Aug 2017
FDA approval brings first gene therapy to the United States
30 August 2017 - CAR T-cell therapy approved to treat certain children and young adults with B-cell acute lymphoblastic leukaemia.
The U.S. FDA issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.
The FDA approved Kymriah (tisagenlecleucel) for certain paediatric and young adult patients with a form of acute lymphoblastic leukaemia (ALL).
Kymriah, a cell-based gene therapy, is approved in the United States for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse.
