Lynparza gains added indication in Europe

The European Commission has approved Lynparza (olaparib) as a monotherapy for the treatment of adult patients with germline BRCA1/2-mutations (gBRCAm), and who have human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer.

This is the third indication for AstraZeneca (LSE: AZN) and Merck & Co's (NYSE: MRK) Lynparza in the European Union, and is the first PARP inhibitor approved in Europe for patients with this difficult-to-treat disease. The drug generated sales of $647 million for AstraZeneca in 2018, representing growth of 118% on the previous year.

Under the licensed indication, patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless they were unsuitable 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.