MHRA approves olaparib for high-risk, early-stage breast cancer

The Institute of Cancer Research, London, celebrates the news that the precision medicine olaparib has been approved by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), for patients with high-risk, early-stage breast cancer and inherited faults in their BRCA1 or BRCA2 genes.

The drug offers women diagnosed with early-stage, inherited breast cancer an additional treatment that can help prevent their cancer recurring and improve their survival.

The approval grants marketing authorisation for the use of olaparib in the UK. An appraisal by NICE is currently under way to determine whether olaparib will be offered through the NHS for the same group of women and a decision is expected by early 2023.

The authorisation in the UK follows similar approvals in March by the US Food and Drug Administration and more recently in Europe by the European Medicines Agency (EMA).

In March, the phase III OlympiA trial showed that adding olaparib to standard treatment for patients with high-risk, early-stage breast cancer and inherited faults in their BRCA genes cut their risk of death by 32 per cent after an average three and a half years follow up.

The trial also previously met its primary end point showing that olaparib reduced the risk of breast cancer returning in these patients by 42 per cent. This endpoint was reported earlier than expected, after an average two and a half years follow up.

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 is coordinated by the Breast International Group (BIG).

Professor Tutt and colleagues at the Breast Cancer Now Toby Robins Research Centre at the ICR were involved in early laboratory research on PARP inhibitors such as olaparib, and their subsequent clinical development.

In the early 1990s, ICR scientists discovered the BRCA2 gene, and a decade later were first to demonstrate that cancer cells with mutations in BRCA1 or BRCA2 were highly susceptible to PARP inhibitors.

ICR scientists including Professor Andrew Tutt and colleagues at The Royal Marsden NHS Foundation Trust also led several early clinical trials that showed the benefits of olaparib for patients with BRCA1 or BRCA2 mutations in their tumours.

The BRCA1 and BRCA2 genes are involved in DNA repair. Around 5 to 10 per cent of breast cancer cases occur because of inherited mutations in these genes.

Olaparib is currently licensed in the UK, EU, and US for patients with advanced breast cancer who have inherited faults in their BRCA1 or BRCA2 genes and have previously received treatment with chemotherapy, and for some cancers of the ovaries. However, it is not yet routinely available on the NHS for patients with advanced breast cancer.

Professor Andrew Tutt, Global Chair of the OlympiA Phase III trial and 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 the UK for patients with this inherited form of breast cancer. For patients with high-risk, early-stage breast cancer, including those with inherited BRCA mutations, recurrence rates remain unacceptably high, with more than one in four of these patients seeing their cancer return following surgery and other current treatments.

“Olaparib offers the first treatment that exploits the specific biology of this inherited type of breast cancer to reduce the risk of cancer returning and improve survival in women diagnosed with early-stage disease. I am hopeful it will become a new standard of care.”

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

“Today’s licensing decision is a really important step for UK patients. Women diagnosed with early-stage, inherited breast cancer could now soon have an additional treatment option to help keep them free of cancer, and to extend their lives. We would urge NICE and other appraisal bodies to work with the manufacturer to make olaparib available on the NHS at an affordable price as soon as possible.

“The ICR’s researchers played a crucial role in in genetically targeting olaparib at weaknesses in BRCA-mutant cancers, and in later developing the drug for patients in clinical trials. It’s fantastic that ICR’s research has contributed to the approval of an efficient personalised treatment for women diagnosed with early-stage, inherited breast cancer.”