Second CAR T-cell therapy receives FDA approval
medwireNews: The US FDA has granted approval for use of the chimeric antigen receptor (CAR) T-cell immunotherapy axicabtagene ciloleucel in adults with some forms of non-Hodgkin lymphoma.
Axicabtagene ciloleucel may now be used in patients who have previously received at least two lines of therapy for diffuse large-B cell lymphoma, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma and diffuse large B-cell lymphoma arising from follicular lymphoma.
The CAR T-cell therapy was given Priority Review, Breakthrough Therapy and Orphan Drug designation after the ZUMA-1 trial findings indicated a complete remission rate of 51% for patients with refractory or relapsed large B-cell lymphoma.
The decision follows the earlier approval in 2017 of the CAR T-cell immunotherapy tisagenlecleucel for patients with B-cell precursor acute lymphoblastic leukemia who are aged less than 25 years.
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