AstraZeneca: US FDA Accepts Regulatory Submission for Lynparza
12 November 2018 - 6:51PM
Dow Jones News
By Oliver Griffin
AstraZeneca PLC (AZN.LN) said Monday that the U.S. Food and Drug
Administration has accepted regulatory submission for its Lynparza
maintenance therapy, which is being developed to treat advanced
ovarian cancer.
The pharmaceutical company said the submission of the drug,
which it is developing with Merck & Co. Inc. (MRK) as part of a
global strategic oncology collaboration, is based on positive
results from the pivotal Phase III SOLO-1 trial.
The company said Lynparza was the first regulatory submission in
the U.S. for a poly ADP ribose polymerase, or PARP, inhibitor as a
first-line maintenance treatment for advanced ovarian cancer.
Approval of the drug would expand the use of Lynparza to patients
in the first-line setting following platinum-based chemotherapy,
AstraZeneca said.
AstraZeneca said Lynparza is currently approved in more than 60
countries for the treatment of platinum-sensitive relapsed ovarian
cancer.
Write to Oliver Griffin at oliver.griffin@dowjones.com;
@OliGGriffin
(END) Dow Jones Newswires
November 12, 2018 02:36 ET (07:36 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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