The European Commission (EC) has approved AstraZeneca drug Lynparza (olaparib) as a monotherapy to treat locally-advanced or metastatic breast cancer in adults.
The drug, which is being co-developed with MSD, is indicated for patients with germline BRCA1/2-mutations (gBRCAm) who are human epidermal growth factor receptor 2 (HER2)-negative.
It can only be prescribed for patients who have had treatment with an anthracycline and a taxane in the adjuvant or metastatic setting, unless they were not eligible for these therapies.
In addition, the drug can be given to patients whose hormone receptor (HR) positive breast cancer progressed during or following endocrine therapy, or those who are not considered suitable for this therapy.
Lynparza is a PARP inhibitor designed to block DNA damage response in tumours with a homologous recombination repair (HRR) deficiency. It is said to be the first PARP inhibitor approved for this patient population in the EU.
AstraZeneca Oncology executive vice-president Dave Fredrickson said: “With this approval, Lynparza provides patients throughout the EU with a targeted and oral chemotherapy-free treatment option for a difficult-to-treat cancer.
“It also reinforces the importance of testing for biomarkers including BRCA, hormone receptor and HER2 expression, helping physicians to make the most informed treatment decisions for patients.”
The EC approval is based on results from the randomised, open-label, Phase III OlympiAD trial conducted to assess Lynparza, compared to a physician’s choice of chemotherapy.
Patients treated with the drug achieved a statistically-significant median progression-free survival improvement of 2.8 months, and 52% objective response rate compared to 23% in the chemotherapy group.
The most common Lynparza-related adverse reactions observed in the trial were nausea, anaemia, fatigue, vomiting, neutropenia, respiratory tract infection, leukopenia, diarrhoea and headache.
Last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion on the use of the drug for this patient population.
This EC approval marks the third indication for Lynparza in the European Union (EU). AstraZeneca and MSD intend to expand the use of the drug in multiple cancer settings.