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Pharmaceuticals / Submissions and Approvals

FDA Advisory Committee Sees Benefits of CAR-T Leukemia Therapy

July 17, 2017
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An FDA advisory committee voted unanimously Wednesday in favor of the risk-benefit profile for Novartis’ BLA for an innovative new cancer therapy.

The Oncologic Drugs Advisory Committee heard from representatives of the company and the FDA on  Novartis’ tisagenlecleucel-T suspension for intravenous use, for treatment of pediatric and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia.

The expert group hailed the T-cell therapy as potentially game-changing. Chairperson Bruce J. Roth, a professor of medicine in the division of oncology at the Washington University School of Medicine, noted concerns about long-term toxicity associated with the drug, but said “you have to be a long-term survivor to experience long-term toxicity.”

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