AstraZeneca granted priority review from FDA for Lynparza in metastatic breast cancer
AstraZeneca said on Wednesday that it and Merck & Co have been granted priority review by the US Food and Drug Administration for a supplemental new drug application for the use of Lynparza (olaparib) tablets in patients with metastatic breast cancer who have been previously treated with chemotherapy.
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The London-listed pharmaceuticals giant said a prescription drug user fee act date is set for the first quarter of 2018. It added that this is the first submission for a poly ADP-ribose polymerase (PARP) inhibitor outside ovarian cancer and the third indication submission for Lynparza in the US.
The supplemental new drug application is based on positive results from the phase III Olympiad trial published in the New England Journal of Medicine.
Lynparza was first approved in December 2014 as a capsule formulation, making it the first ever PARP inhibitor to be approved. Since then, it has been used to treat more than 3,000 advanced ovarian cancer patients. The tablets are currently being tested in a range of tumour types including breast, prostate and pancreatic cancers.