AstraZeneca Says FDA Approves Lynparza for Prostate Cancer
May 20 2020 - 2:46AM
Dow Jones News
By Anthony O. Goriainoff
AstraZeneca PLC said Wednesday that Lynparza has been approved
in the U.S. for use in patients with prostate cancer.
The London-listed drugmaker said the U.S. Food and Drug
Administration approved the drug based on results from the phase 3
PROfound trial , which were published in the New England Journal of
Medicine.
The company said that following the approval it will receive a
regulatory milestone payment from MSD Research Laboratories of $35
million, and that this will be booked as collaboration revenue
during the second quarter of 2020.
The company said Lynparza is currently under regulatory review
in the European Union and other jurisdictions as a treatment for
men with homologous recombination repair gene-mutated metastatic
castration-resistant prostate cancer.
Write to Anthony O. Goriainoff at
anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
May 20, 2020 02:31 ET (06:31 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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