FDA Expedites Development of AstraZeneca's Blood Cancer Drug Acalabrutinib
August 01 2017 - 3:29AM
Dow Jones News
By Razak Musah Baba
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.
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.
Write to Razak Musah Baba at razak.baba@wsj.com; Twitter:
@Raztweet
(END) Dow Jones Newswires
August 01, 2017 03:14 ET (07:14 GMT)
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