- AstraZeneca said the US Food and Drug Administration had granted breakthrough therapy designation for its chronic lymphocytic leukaemia drug.

The breakthrough therapy designation (BTD) status for Calquence, administered as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia, was granted following positive results from the interim analyses of the Elevate-Tn and Ascend Phase III clinical trials.

An FDA BTD was designed to accelerate the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results which may have demonstrated substantial improvement on a clinically-significant endpoint over currently-available medicines.

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