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

In August 2017, the U.S. Food and Drug Administration (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.

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