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EMA recommends approval of olaparib for treatment of high-risk, early breast cancer

The Institute of Cancer Research, London, strongly welcomes the news that olaparib has been recommended by the European Medicines Agency (EMA) to treat people with high-risk, early-stage breast cancer who have inherited faults in their BRCA1 or BRCA2 genes.

The next step is for the European Commission to grant marketing authorisation, a process likely to take place in the next few months. Once this licensing step is completed, people in the EU with early breast cancer and BRCA mutations, who have already been treated with chemotherapy, either before or after surgery, will be a step closer to accessing olaparib, on its own or in combination with hormone therapy.

The recommendation follows the latest findings from the Phase III OlympiA trial, which showed that adding the targeted drug olaparib to standard treatment cuts the risk of women dying by 32 per cent – resulting in more women remaining cancer free and becoming breast cancer survivors.

Professor Andrew Tutt at The Institute of Cancer Research (ICR) and King’s College London is Chair of the Steering Committee for the OlympiA trial, which was coordinated by the Breast International Group (BIG). Professor Tutt was also involved in early laboratory research at the Breast Cancer Now Toby Robins Research Centre at the ICR on PARP inhibitors such as olaparib, and their subsequent clinical development.

Olaparib, which is taken orally, was recently approved in the US for the same group of people – those with high-risk, early-stage breast cancer who have inherited faults in their BRCA1 or BRCA2 genes.

Olaparib is also approved for use in the US, EU and UK for the treatment of patients with advanced breast cancer who have inherited faults in their BRCA1 or BRCA2 genes and were previously treated with chemotherapy.

OlympiA Steering Committee Chair Professor Andrew Tutt, Professor of Oncology at The Institute of Cancer Research, London, and King’s College London said:

“Olaparib is the first PARP inhibitor to increase the chances of curing people with early-stage breast cancer after initial treatment.

“Most breast cancers identified at an early stage are likely to be cured, but even with the best standard treatments, there is a high-risk group of women who are still likely to see their cancer return. Olaparib is a targeted treatment option that can keep these women with inherited high-risk breast cancer due to BRCA1/2 gene faults free of disease.

“Today’s recommendation brings olaparib a step closer to approval in Europe for people with high-risk, early-stage breast cancer. The next steps are for the MHRA to make a recommendation in the UK, and for NICE to carry out its appraisal, so that NHS patients in England can access olaparib without delay. We hope these processes can proceed as quickly as possible given the EMA recommendation.”

Professor Kristian Helin, Chief Executive of The Institute of Cancer Research, London, said:

“Science carried out at the ICR underpinned the development of PARP inhibitors like olaparib. Initially shown to benefit those with advanced breast, ovarian and prostate cancers, olaparib could now be used to reduce the risk of disease returning in early-stage breast cancer.

“It is tremendously exciting that the OlympiA trial shows olaparib could be successfully used to treat women with early-stage breast cancer and inherited BRCA mutations to improve their survival outcomes.

“BRCA1 and BRCA2 mutations are the most common cause of hereditary breast cancer – around 5 to 10 percent of breast cancers are the result of mutations in these genes.

This means that thousands of people with early breast cancer could benefit from being treated with olaparib, and I look forward to seeing BRCA1 and BRCA2 testing used more widely for those diagnosed with early-stage breast cancer, so that we can identify those likely to benefit from this game-changing targeted treatment.”