AstraZeneca Suspends Recruitment in Clinical Trials on Head and Neck Cancer
28 October 2016 - 4:44AM
Dow Jones News
By Denise Roland
AstraZeneca PLC said it had suspended enrollment into two large
clinical trials on head and neck cancer while it investigates
whether the treatment is causing patients to bleed.
Cambridge, U.K.-based AstraZeneca said it had observed bleeding
in some patients as part of routine safety monitoring of the two
trials and had paused recruitment to analyze those incidents.
It said bleeding is a known complication in treatments of head
and neck cancers "due to the nature of the underlying disease, the
proximity of tumors to major blood vessels and use of prior cancer
therapies, which may involve surgery and radiation."
The company said it had submitted its analysis of the bleeding
events to the U.S. Food and Drug Administration for review and was
working closely with the agency to resume new patient enrollment as
soon as possible.
The trials in question are testing whether a drug called
durvalumab, used alone or in combination with one of Astra's other
experimental cancer medicines, prolongs survival in patients with
head and neck cancer. Patients already enrolled in the trial will
continue to take the drugs, according to a company spokesman.
Astra also is testing these drugs in lung and bladder cancer,
but said the suspension related only to head-and-neck-cancer
patients.
Durvalumab and other new cancer drugs are key to AstraZeneca
hitting the ambitious growth targets it unveiled in 2014 to defend
against an unsolicited, and ultimately failed, takeover bid by
Pfizer Inc. The company aims to increase revenue to $45 billion by
2023, compared with $25 billion in 2015. AstraZeneca predicts that
durvalumab will generate $6.5 billion in annual revenue at its
peak, if approved as a treatment for several tumor types.
AstraZeneca shares trading in London closed down 3.4% at
GBP46.15. Its American depositary receipts in New York were down
4.4% at $28.28.
Write to Denise Roland at Denise.Roland@wsj.com
(END) Dow Jones Newswires
October 27, 2016 13:29 ET (17:29 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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