H1 financial results show AstraZeneca’s revenues grew by 23 percent in 2021, with $14.37 billion attributed to activities aside from COVID-19 vaccine sales.
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In the Phase III OlympiA trial, Lynparza® (olaparib) reduced the risk of cancer recurrences or death by 42 percent in patients with BRCA-mutated high-risk early breast cancer.
The recommendation will allow more data to be collected about the combination treatment while allowing patients with high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer to access the medication.
The OlympiA trial will conduct its primary analysis early, after the Independent Data Monitoring Committee found it met its primary endpoint in BRCA mutated early breast cancer patients.
Lynparza’s approval was based on results from a Phase III clinical trial in which it improved overall survival and progression-free survival in patients with certain prostate cancers.
The FDA has approved Lynparza as a first-line treatment after it reduced the risk of disease progression or death by 47 percent in patients.
The UK NICE has extended its approval for olaparib, updating its formulation from eight capsules twice a day to two tablets twice daily.
BRCA-mutated advanced ovarian cancer treatment has been approved by the European Commission.