A precision medicine for early-stage breast cancer has been approved by the European Medicines Agency (EMA).
Developed by AstraZeneca and Merck & Co (MSD) under the brand name Lynparza, the treatment is a precision medicine which blocks DNA damage response (DDR) in cells or tumours that have a deficiency in homologous recombination repair (HRR), such as those with mutations in BRCA1 and/or BRCA2.
The treatment is being investigated in the Phase III OlympiA trial and the latest results show that adding olaparib to standard treatment for patients with high-risk, early-stage breast cancer and inherited faults in their BRCA genes can cut their risk of dying by 32%.
The OlympiA trial was the first to show that olaparib, which exploits a specific weakness in cancers with mutations in their BRCA1 or BRCA2 genes, is beneficial for patients when their cancer is at an early stage.
It’s estimated that around 5-10% of breast cancers occur due to the genes – BRCA1 or BRCA2 – that are involved in DNA repair.
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “With this approval, Lynparza is now the first and only PARP inhibitor available for patients with germline BRCA-mutated HER2-negative early breast cancer in Europe. We can now bring the benefits of Lynparza to this earlier setting to help reduce the risk of life-threatening recurrence.”
OlympiA Steering Committee Chair Professor Andrew Tutt, Professor of Oncology at The Institute of Cancer Research, London, and King’s College London, said: “Today’s approval marks a new era of care in Europe for patients with an inherited form of breast cancer. The next step will be for the MHRA to make a recommendation in the UK, followed by a NICE appraisal so that UK patients can access this targeted drug on the NHS.”
“For women with inherited mutations in their BRCA1 or BRCA2 genes and early-stage, high-risk breast cancer, olaparib offers a personalised treatment that exploits the specific biology of their cancer to improve their chances of a cure.”