Merck, AstraZeneca’s sNDA for breast cancer treatment granted priority review by the FDA

Merck & Co. Inc. and AstraZeneca PLC said Tuesday that their supplemental New Drug Application (sNDA) for its breast cancer treatment Lynparza has been accepted and granted priority review by the U.S. Food and Drug Administration. Lynparza’s sNDA is for the adjuvant treatment of patients with BRCA-mutated, human epidermal growth factor receptor 2-negative high-risk early breast cancer who have already been treated with chemotherapy. The sNDA was based on results from a Phase 3 trial that showed Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival, reducing the risk of invasive breast cancer recurrence, second cancers or death by 42% versus placebo. Merck’s stock slipped 0.2% in premarket trading, but outperformed the 1.2% drop in futures for the Dow Jones Industrial Average ahead of the open.

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