First CAR T-Cell Therapy Unanimously Recommended by FDA Advisory Committee for Treatment of B-Cell ALL in Children and Young Adults

Web Exclusives - FDA Approvals, News & Updates

On July 12, 2017, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended the approval of Novartis’s CTL019 (tisagenlecleucel)—the first ever chimeric antigen receptor (CAR) T-cell therapy to be presented to the FDA for review for the treatment of pediatric patients and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).

The committee’s recommendation was based on a review of ELIANA, the first pediatric global CAR T-cell therapy clinical trial. The results from a multicenter trial and a single-center trial that assessed the drug’s safety and efficacy in pediatric patients and young adults with relapsed or refractory B-cell ALL also supported the recommendation.

Among the 63 patients who received CTL019 between April 2015 and August 2016, 63 (82.5%) patients experienced diseased remission, and 11 patients died.

“It’s a new world, an exciting therapy,” said Gwen Nichols, MD, Chief Medical Officer of the Leukemia & Lymphoma Society, which funded some of the research related to this treatment.

The FDA agreed to review the manufacturer’s Biologics License Application under its priority review status; if approved, CTL019 would become the first CAR T-cell therapy in the United States.

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Last modified: August 10, 2017
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