AstraZeneca and MSD's Lynparza treatment approved in EU for certain cases of advanced breast cancer
The European Commission has approved the use of the drug Lynparza, developed by AstraZeneca and MSD, for the treatment of certain cases of hard-to-treat breast cancer.
It offers patients in the EU with germline BRCA-mutated HER2-negative advanced breast cancer an alternative to chemotherapy.
The approval follows the OlympiAD trial, which tested the drug against the physician’s choice of chemotherapy and found it improved progression-free survival by an average of 2.8 months - seven months in total, compared to 4.2.
It reduced the risk of death or disease progression by 42 per cent compared to chemotherapy in the Phase III trial.
Dave Fredrickson, executive vice president, oncology, at AstraZeneca, 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.”
Lynparza - the brand name for olaparib - has already been approved for multiple indications in advanced ovarian cancer and metastatic breast cancer and has been taken by more than 20,000 patients worldwide.
It is being commercialised jointly by AstraZeneca - which will move into its new Cambridge Biomedical Campus global headquarters and R&D centre next year - and MSD. This is the third indication for Lynparza in the EU, and the companies are working to deliver the drug to patients with other cancer types.
Roy Baynes, senior vice president and head of global clinical development, chief medical officer, MSD Research Laboratories, said: “In the OlympiAD trial, which supported this approval, Lynparza demonstrated a meaningful improvement in progression-free survival compared to chemotherapy in patients with germline BRCA-mutated metastatic breast cancer. We look forward to making this new option available across the EU, where we hope it will improve outcomes for many patients.”
Under the licensed indication, patients should previously have been treated with an anthracycline and a taxane, unless unsuitable for those treatments. Patients with hormone receptor (HR) positive breast cancer should also have progressed on or after prior endocrine therapy, unless unsuited.
Lynparza is a PARP inhibitor and blocks the DNA damage response in cells/tumours with mutations.
The decision follows other recent approvals for AstraZeneca.
IMFINZI - the brand name name for durvalumab - is now available on the NHS in England to cure stage 3 lung cancer, thanks to the Cancer Drugs Fund.
And in Japan, Forxiga (dapagliflozin) was approved as an oral adjunct treatment to insulin for adults with type-1 diabetes.