Biochemical Engineering Special Interest Group
biological engineering professionals
13 July 2017

Novartis CAR-T therapy wins FDA support

Novartis’ landmark CAR-T cancer therapy has won the unanimous support of the FDA’s advisory committee. The clean sweep followed a meeting in which CTL019’s stellar efficacy data outshone concerns about safety and manufacturing, setting Novartis up to win the first FDA CAR-T approval by October 3. Novartis entered the meeting holding the trump card of an 83% complete remission rate, a figure that blows that achieved by existing treatments for kids with B-cell acute lymphoblastic leukemia out of the water. Source: Fierce Biotech 13/7/2017

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