We may not have to wait much longer for the first FDA-approved CAR-T cell therapy. The Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recently recommended Novartis’ CTL019 CAR-T cell therapy for FDA approval by unanimous decision, a major step forward for the groundbreaking biologic.

CTL019, indicated for pediatric and young adult r/r B cell acute lymphoblastic leukemia (ALL) patients, is currently under Priority Review by the FDA.


About CTL019

ALL is the most common form of cancer among US children, but has limited treatment options and low disease-free survival rates. A research team out of the University of Pennsylvania developed the CTL019 CAR-T cell therapy before collaborating with Novartis for further development and commercialization efforts.

Although r/r B Cell ALL represents only a fraction of the total cancer diagnoses in the US, FDA approval of the CTL019 therapy would be a breakthrough for CAR-T cell therapies and would undoubtedly lead to more innovations and treatment options in the near future, many of which are currently in development by Novartis and other companies.

For more on CTL019, including stories from patients in Novartis’ studies, see the story in the New York Times.

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