AstraZeneca adds another indication for Lynparza in the US
By Josh White
Date: Monday 12 Nov 2018
(Sharecast News) - AstraZeneca, and its partner Merck & Co, announced on Monday that the US Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for priority review, for the use of Lynparza (olaparib) tablets as a maintenance treatment in patients with newly-diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer who were in complete or partial response following first-line standard platinum-based chemotherapy.
The FTSE 100 drugmaker said a Prescription Drug User Fee Act date was set for the first quarter of 2019.
It said it was is the first US regulatory submission acceptance for a poly ADP-ribose polymerase (PARP) inhibitor in the first-line maintenance setting for advanced ovarian cancer, and if approved, would be the fourth indication for Lynparza in the US.
"This submission was based on positive results from the pivotal Phase III SOLO-1 trial," AstraZeneca's board explained.
"The trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival for Lynparza compared to placebo, reducing the risk of disease progression or death by 70% in patients with newly-diagnosed, BRCAm advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy."
AstraZeneca said that, of those receiving Lynparza, 60% remained progression-free at 36 months compared to 27% of women in the placebo arm.
"These data were recently presented for the first time at the ESMO 2018 Congress, and published online in the New England Journal of Medicine."
Lynparza was currently approved in more than 60 countries for the treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status.
It was also approved in several countries, including the US and Japan, for germline BRCAm HER2-negative metastatic breast cancer, with regulatory reviews underway in the EU, Japan and other markets.
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