LONDON – British drug maker AstraZeneca Plc said the US Food and Drug Administration approved its cancer drug, jointly developed with US-based Merck & Co , as a treatment for patients with early-stage breast cancer with certain mutations.
AstraZeneca said 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 has 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% 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.
In 2020, there were 2.3 million women diagnosed with breast cancer and 685, 000 deaths globally, according to the World Health Organization.
Following the US approval for Lynparza, AstraZeneca will receive a regulatory milestone payment of $175 million from Merck.
