The FDA Unanimously Recommends Approval of the First CAR-T Therapy

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The FDA’s recommendation for Novartis’ CTL019 (tisagenlecleucel) opens the way to a new generation of cell-based immunotherapies to treat cancer. 

Yesterday, the FDA’s Oncologic Drugs Advisory Committee (ODAC) held a hearing to evaluate Novartis CTL019. The committee voted unanimously (10-0) in favor of the therapy, which the FDA will certainly weigh in when making the final decision on approval in October. If positive, CTL019 would be the first CAR-T therapy in the market.

The news is not only good for Novartis, which expects peak sales of at least $1Bn. The FDA’s recommendation validates the CAR-T technology many others are developing, including Juno Therapeutics, Cellectis, Celyad, and, most notably, Kite Pharma, which is expecting a decision on the approval of its own CAR-T candidate in November.

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Tia Rai

Research Assistant Professor - Scientific Writing, The Hormel Institute, University of Minnesota