LONDON – The U.S. Food and Drug Administration has agreed to speed up the process required for development and regulatory review of AstraZeneca PLC's (AZN.LN) blood cancer drug acalabrutinib.
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Pharmaceutical firm AstraZeneca and its hematology research and development centre Acerta Pharma, said today that the FDA has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
The Breakthrough Therapy Designation is designed to expedite 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 demonstrate substantial improvement on a clinically-significant endpoint over available medicines and when there is significant unmet medical need.
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(END) Dow Jones Newswires
August 01, 2017 03:14 ET (07:14 GMT)