EU backs Cambridge-born Lynparza for early breast cancer

AstraZeneca and MSD's Lynparza (olaparib) – born in a Cambridge laboratory – has been recommended for marketing authorisation in the European Union, providing another boost for breast cancer patients.

The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on results from the OlympiA Phase III trial.

In the trial, Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42 per cent versus placebo.

Lynparza also demonstrated a statistically significant and clinically meaningful improvement in overall survival, reducing the risk of death by 32 per cent versus placebo. The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials.

Breast cancer is the most diagnosed cancer worldwide with an estimated 2.3 million patients diagnosed in 2020. Around 90 per cent of all breast cancer patients are diagnosed with early breast cancer.

Susan Galbraith, Executive Vice-President, Oncology R & D at AstraZeneca, said: “If approved, Lynparza will become a new targeted treatment option for patients with germline BRCA-mutated HER2-negative early breast cancer in Europe. 

“By treating patients with curative-intent as early as possible in their disease, we hope to avoid life-threatening recurrence and give people more time with their loved ones.”

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 many other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial. In the EU, this indication also includes patients with locally advanced breast cancer.

The origins of Lynparza lay in Professor Steve Jackson’s Cambridge lab and his company KuDOS which AstraZeneca acquired for $106 million in 2006.