AstraZeneca's Lynparza approved in Japan
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AstraZeneca and MSD's Lynparza has been approved in Japan for the treatment of patients with BRCA-mutated (BRCAm), HER2-negative early breast cancer at high risk of recurrence, the companies said on Thursday.
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The approval by Japan’s Ministry of Health, Labour, and Welfare was based on results from the OlympiA Phase III trial.
In the trial, Lynparza demonstrated a “statistically significant and clinically meaningful improvement” in invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% versus a placebo.
Lynparza also demonstrated a statistically significant and clinically meaningful improvement in overall survival, reducing the risk of death by 32% versus placebo, AstraZeneca said in a statement.
Reporting by Frank Prenesti at Sharecast.com