Research & Development
AstraZeneca reports Lynparza granted EU approval for early breast cancer
4 August 2022 -

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

The European Commission approved Lynparza as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

This decision follows a recommendation by the Committee for Medicinal Products for Human Use (CHMP), based on 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.

Following this approval for Lynparza in the EU, AstraZeneca will receive a regulatory milestone payment from MSD of USD75m.

Login
Username:

Password:


Related Headlines