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First approval in sight for Novartis’ CAR-T therapy after expert panel vote

First approval in sight for Novartis’ CAR-T therapy after expert panel vote

On July 12, in a historic move, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 10–0 in favor of approving CTL019 (tisagenlecleucel), a CD19-targeting chimeric antigen receptor (CAR) T-cell therapy developed by Novartis for treating relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) in children and young adults. The committee’s unanimous backing opens the door to approval of the therapy by the US Food and Drug Administration (FDA) on or before October 3. The US, which has lagged behind Europe in approving both gene therapy and cell therapy, has now taken a lead in adopting an innovative immuno-oncology treatment that combines elements of each modality—and which addresses a real and sizeable unmet need.  Read more