AstraZeneca's Lynparza approved in Japan

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.

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