AstraZeneca has said the US Food and Drug Administration (FDA) approved its cancer drug, jointly developed with US-based Merck & Co, as a treatment for patients with early-stage breast cancer with certain mutations.
The company also said that the drug, Lynparza, was approved for patients with a form of genetically mutated high-risk early-stage breast cancer called BRCA-mutated HER2-negative, who have already been treated with chemotherapy either before or after surgery.
The approval was based on results from a late-stage study in which the drug showed statistically significant and clinically meaningful improvement in invasive disease-free survival, reducing the risk of invasive breast cancer recurrences and second cancers or death by 42 per cent compared with placebo.
Lynparza leads a class of drugs known as PARP inhibitors, which keep cancer cells damaged by chemotherapy from repairing themselves. It is a key asset for AstraZeneca with approvals for ovarian, prostate and pancreatic cancers.
Following the US approval for Lynparza, AstraZeneca will receive a regulatory milestone payment of $175 million from Merck.
Edits by EP News Bureau
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