FDA Grants Breakthrough Therapy Designation for AstraZeneca's Imfinzi
July 31 2017 - 2:48AM
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) new lung cancer drug Imfinzi
(durvalumab).
Pharmaceutical firm AstraZeneca and MedImmune, its global
biologics research and development arm, said Monday that the FDA
has granted Breakthrough Therapy Designation for Imfinzi
(durvalumab) for the treatment of patients with locally-advanced,
unresectable non-small cell lung cancer whose disease has not
progressed following platinum-based chemoradiation 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.
"Imfinzi is the first immuno-oncology medicine to show a
clinically-significant benefit in this earlier, non-metastatic
setting, so following the Breakthrough Designation we hope to bring
it to patients as soon as possible," Sean Bohen, Executive Vice
President, Global Medicines Development and Chief Medical Officer
at AstraZeneca, said.
Write to Razak Musah Baba at razak.baba@wsj.com; Twitter:
@Raztweet
(END) Dow Jones Newswires
July 31, 2017 02:33 ET (06:33 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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