Science-led biopharmaceutical company AstraZeneca Plc (LON:AZ) and pharmaceutical company MSD Inc (Merck Sharp & Dohme, known as Merck & Co Inc in the US and Canada) (NYSE:MRK) announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the use of Lynparza (olaparib) tablets as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.

The companies said this positive opinion is based on data from the randomised, open-label, Phase III OlympiAD trial, which tested Lynparza against the physician's choice of chemotherapy. The global, randomised, open-label, multi-centre phase III trial of 302 patients, assessed the efficacy and safety of Lynparza tablets (300mg twice daily) compared to the physician's choice of chemotherapy (capecitabine, eribulin or vinorelbine). 205 patients were randomised to receive Lynparza and 97 patients were randomised to receive chemotherapy.

According to the companies, patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.

Lynparza is being jointly developed and commercialised by AstraZeneca and MSD. It is approved for multiple indications in advanced ovarian cancer and metastatic breast cancer and has been used in over 20,000 patients worldwide. It is currently approved in over 60 countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCAstatus. It is approved in the US for 1st-line maintenance therapy in BRCAm advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in several countries, including the US and Japan, for germline BRCAm HER2-negative metastatic breast cancer previously treated with chemotherapy. Regulatory reviews are underway in other jurisdictions.

Also, on 26 February 2019, AstraZeneca and MSD had announced that Lynparza has become the first PARP inhibitor to demonstrate benefit in germline BRCAm metastatic pancreatic cancer in the phase III POLO trial.

In July 2017, AstraZeneca and MSD had announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world's first PARP inhibitor and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and selumetinib in combination with other potential new medicines and as a monotherapy. Independently, the companies will develop Lynparza and selumetinib in combination with their respective PD-L1 and PD-1 medicines.

AstraZeneca focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.