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In August 2017, the FDA took historic action in granting the first approval of gene therapy to tisagenlecleucel. This landmark step brought CAR T-cell therapy to the commercial space and heralded a new era in managing refractory B-cell malignancies and FDA oversight of gene-modified therapies.See related article by O'Leary et al., p. 1142.

First CAR to Pass the Road Test: Tisagenlecleucel's Drive to FDA Approval