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Novartis: FDA advisers recommend approval of leukemia drug.

(CercleFinance.com) - An advisory committee to the US Food and Drug Administration has recommended that the agency approves Novartis' CTL019 for young patients with B-cell acute lymphoblastic leukemia.


The panel unanimously voted that the investigational chimeric antigen receptor T cell (CAR-T) therapy should be used for child and young adult patients.

Acute lymphoblastic leukemia comprises approximately 25% of cancer diagnoses among children under 15 years old and is the most common childhood cancer in the US.

The FDA is not required to follow the recommendation of its expert advisory panels, but in general does.



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