Following a unanimous recommendation by the FDA’s Oncologic Drugs Advisory Committee, a BLA for Novartis tisagenlecleucel chimeric antigen receptor T-cell (CAR-T) therapy was approved. The event was cited as “historic…gene-editing technology,” and according to an editorial published in Nature, an example of why scientists “must step-up…to help regulators assess and license the therapies” that are products of laboratory discoveries and offer potential for new treatments.
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