Olaparib is a breast cancer treatment that could save lives. However, in November 2022, it was provisionally rejected for use on the NHS in England.
In response, we launched a campaign, calling on pharmaceutical company, AstraZeneca, NICE and NHS England to find a solution to make olaparib available to the women who could benefit from it.
Over 70,000 sign our petition
Our Chief Executive has now written to AstraZeneca, NICE and NHS England on behalf of the more than 70,000 people who backed the campaign and signed our petition.
We want to say a massive thank you to everybody who added their name and helped us send the strongest message possible that this drug needs to be made available on the NHS.
We hope to hear a final decision soon and we will update you as soon as we do.
To find out about the outcome of the campaign and keep up to date with our other work, please sign up for campaign updates below.
“It’s daunting to know that your breast cancer is less common and more aggressive than other types of breast cancer, with a higher risk of returning in the years immediately following treatment. I feel incredibly lucky to have been given the opportunity to benefit from olaparib. Given the significant reduction in the risk of breast cancer recurring that it provides It’s vital that other eligible women with primary breast cancer are able to benefit from olaparib too.”
A patient with BRCA positive, primary triple negative breast cancer, who has been receiving olaparib via the drug company’s early access programme.
Frequently asked questions
What is Olaparib?
Olaparib is a PARP inhibitor which is a type of targeted (biological) therapy. PARP inhibitors have been developed to treat cancers with changes in BRCA1 or BRCA2 genes.
PARP stands for poly-ADP ribose polymerase. It’s a protein that helps cells repair themselves if they become damaged. PARP inhibitors stop the PARP protein from repairing cancer cells.
Two inherited altered genes, BRCA1 and BRCA2, increase the risk of breast cancer developing. Cancer cells with faulty BRCA genes are already less able to repair themselves if they become damaged. Adding PARP inhibitor drugs blocks another way cancer cells can repair themselves and causes them to become too damaged to survive.
Olaparib is manufactured by the drug company AstraZeneca.
Olaparib was licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) in this indication in September 2022.
Who would be eligible for olaparib?
In the trial, eligible patients had received at least 6 cycles of neoadjuvant or adjuvant chemotherapy containing a taxane, an anthryacline, or both, had completed surgery and had completed adjuvant radiotherapy, if indicated.
High-risk in OlympiA was determined by one of the following:
- Triple negative: either incomplete response to neoadjuvant chemotherapy with residual disease in the breast and/or axilla, or node-positive disease or a primary tumour >2cm in diameter if receiving adjuvant chemotherapy
- Hormone receptor positive: either incomplete response after neoadjuvant chemotherapy with a CPS+EG score of ≥3 or at least 4 pathologically confirmed positive lymph nodes after surgery if receiving adjuvant chemotherapy
Can patients access olaparib currently?
Yes. We understand that AstraZeneca has an early access programme in place for eligible patients to receive adjuvant olaparib free-of-charge. We recommend that patients speak to their treatment team about this as the request to the drug company must come from a medical professional.
This scheme is currently due to close on 31 December. We are calling on AstraZeneca to keep this scheme open until hopefully a positive final decision is reached
What about Scotland, Wales and Northern Ireland?
There are currently no available timelines for the assessment of this treatment by the Scottish Medicines Consortium. This will be dependent upon when the company submits the treatment to the SMC.
Wales and Northern Ireland normally follow NICE, therefore, the provisional rejection by NICE also has implications for patients in these nations.
What is BRCA?
The most common inherited altered genes that increase the risk of breast cancer are BRCA 1 and BRCA2. Around 5-10% of women with breast cancer are thought to carry an altered gene. Those with a BRCA1 mutation have a closer association to developing triple negative breast cancer, whereas BRCA2 mutation tends to result in hormone receptor positive (HER2 negative) breast cancer.
Research highlights that breast cancers associated with germline BRCA 1 and BRCA 2 can be characterised by high-grade disease
Patients with germline BRCA1/2 primary breast cancer with high-risk features remain at increased risk of recurrence following current standard treatment, OlympiA was designed to determine whether one year of adjuvant olaparib could improve outcomes in this population.
How was Breast Cancer Now involved in the development of PARP inhibitors?
Following early work to investigate the PARP protein, in the 2000s two research teams were investigating PARP as a new target for cancer treatment - one based in Newcastle and Sheffield and funded by Cancer Research UK and one at the Breast Cancer Now Toby Robins Research Centre at The Institute of Cancer Research (ICR), London.
The team at Breast Cancer Now’s Research Centre published results of their research in 2005, making the significant discovery of a link between faulty BRCA genes and the PARP protein.
Following these discoveries, the Newcastle and Sheffield research team developed the first PARP inhibitor drug rucaparib.
The team at Breast Cancer Now’s Research Centre began working with a collaborator in Cambridge to develop and test the drug olaparib, going on to show that this PARP inhibitor drug could be used to treat people with breast and ovarian cancers with changes in their BRCA genes.
Breast Cancer Now funded researchers continue to be involved in PARP inhibitor research trying to understand why some cancers might become resistant to PARP inhibitors and what we can do to avoid it. Several research projects funded by Breast Cancer Now are also testing in the lab whether certain PARP inhibitor drugs could be used to treat some oestrogen receptor positive breast cancers and some breast cancers that have spread to the brain.
Does Breast Cancer Now financially benefit from the use of PARP inhibitors?
Breast Cancer Now funded researchers contributed to the discovery and testing of PARP inhibitors. The charity receives a share of royalties from the Institute of Cancer Research for sales of PARP inhibitor drugs being used in a targeted way to treat cancers with changes in BRCA genes, or other similar defects which mean that cancer cells are unable to properly repair their DNA. This includes royalties from sales of olaparib by AstraZeneca and Merck. The charity re-invests the money to fund world-class research and life-changing support for everyone affected by breast cancer.
Through research, Breast Cancer Now is accelerating progress towards fewer cases, fewer deaths and a better quality of life for everyone affected by breast cancer. One way of doing this is protecting the IP that is generated by our research (for instance, by applying for a patent), and then working with others to use the IP to develop new tests or treatments. In most cases, we work with expert IP agencies who monitor our research portfolio and identify projects that have the potential to generate IP.
This means that we receive income based on the IP that we own or where we have a right to a share of any revenue. We use this income to fund more world-class research that could benefit people affected by breast cancer.
Breast Cancer Now has a history of campaigning for new, clinically-effective drugs to reach patients on the NHS, from Keeping Kadcyla, Perjeta Now to the most recent campaign, Time For Trodelvy. This work was driven by the clinical evidence of the treatment and the potential benefit it could bring eligible patients. This is the same for adjuvant olaparib. We input into every single drug appraisal for new breast cancer medicines, ensuring the patient voice is heard loud and clear. Our access to drugs work is driven by the evidence of the treatment, patient need and the benefits it can bring.
We know that a diagnosis of primary breast cancer can cause considerable anxiety to patients as well as their family and friends, including fear or the breast cancer recurring or spreading to other parts of the body where it becomes incurable. And the risk of triple negative breast cancer returning and spreading to other parts of the body in the first few years after treatment is higher than it is for other types of breast cancer. Adjuvant olaparib has been shown to improve invasive disease-free survival, distance disease-free survival and overall survival compared to placebo and it is important that this becomes standard of care on the NHS to give patients access to a potentially life-saving treatment.