AZN AstraZeneca PLC

   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)

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