By Iain Gilbert
Date: Thursday 04 Aug 2022
LONDON (ShareCast) - (Sharecast News) - Drugmaker AstraZeneca's Lynparza has received European Union approval for use in the adjuvant treatment of adult patients with high-risk early-stage breast cancer, including those with germline BRCA mutations.
AstraZeneca said on Thursday that the approval of its breast cancer drug comes on the back of results from the OlympiA Phase III trial published in The New England Journal of Medicine in June 2021 and follows the recommendation for approval in the EU by the Committee for Medicinal Products for Human Use of Lynparza in this setting.
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 placebo.
The FTSE 100-listed group also highlighted that Lynparza had demonstrated a statistically significant and clinically meaningful improvement in overall survival, reducing the risk of death by 32% versus placebo.
As of 0855 BST, AstraZeneca shares were up 0.73% at 10,740.0p.
Reporting by Iain Gilbert at Sharecast.com