AstraZeneca-Merck's Lynparza Wins FDA Approval For Early-Stage Breast Cancer

The FDA has approved AstraZeneca Plc's AZN cancer drug, jointly developed with Merck & Co Inc MRK to treat patients with early-stage breast cancer with certain mutations.

• The agency approved Lynparza (olaparib) 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. Lynparza 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.
• New updated results from the OlympiA trial also showed Lynparza demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS), reducing the risk of death by 32% versus placebo. 
• Following the U.S. approval for Lynparza, AstraZeneca will receive a regulatory milestone payment of $175 million from Merck.
• Separately, the FDA has also approved Myriad Genetics Inc's MYGN BRACAnalysis CDx test as a companion diagnostic to identify patients with germline BRCA-mutated HER2 negative, high-risk early-stage breast cancer who may benefit from Lynparza.
• Price Action: AZN stock is up 1.61% at $61.27 during the premarket session on the last check Monday. MRK stock closed 0.06% higher at $78.30 during after-hours trading on Friday.