Policy & Regulation
AstraZeneca reports Lynparza recommended in EU for early breast cancer
27 June 2022 -

Pharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) announced on Monday that Lynparza (olaparib) has been recommended for marketing authorisation in the European Union for early breast cancer.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of Lynparza as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm) who have HER2-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

This decision was based results from a Phase 3 trial in which Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, new cancers or death by 42% versus placebo.

Lynparza also demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), reducing the risk of death by 32% versus placebo.

In March 2022 Lynparza was approved in the US for the treatment of gBRCAm, HER2-negative high-risk early breast cancer. Lynparza is also approved in the US, EU, Japan and other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy. In the EU, this indication also includes patients with locally advanced breast cancer.

AstraZeneca and Merck & Co Inc (NYSE:MRK), known as MSD outside the US and Canada, formed a global strategic oncology collaboration in July 2017 to co-develop and co-commercialise Lynparza and MEK inhibitor Koselugo (selumetinib) for multiple cancer types.

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