EMA approves early-stage breast cancer treatment  

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.  

Official comments  

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “With this approval, Lynparzais 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 Lynparzato 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.”  

Related Articles

Join FREE today and become a member
of Drug Discovery World

Membership includes:

  • Full access to the website including free and gated premium content in news, articles, business, regulatory, cancer research, intelligence and more.
  • Unlimited App access: current and archived digital issues of DDW magazine with search functionality, special in App only content and links to the latest industry news and information.
  • Weekly e-newsletter, a round-up of the most interesting and pertinent industry news and developments.
  • Whitepapers, eBooks and information from trusted third parties.
Join For Free