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The National Institute for Health and Care Excellence (NICE) has recommended olaparib (Lynparza; AstraZeneca) for treatment of HER2-negative locally advanced or metastatic breast cancer in adults with BRCA1 or BRCA2 gene mutations who have had chemotherapy.
In the final draft guidance, published on 9 January 2025, NICE said around 1,200 people could benefit from the treatment, after reaching a commercial arrangement with manufacturer AztraZeneca.
Olaparib, a daily tablet, is from a class of targeted drugs called Poly (ADP-ribose) polymerase — or PARP — inhibitors. The medicine targets cancers linked to faulty BRCA1 or BRCA2 genes and was initially recommended for some types of ovarian cancer in England and for prostate cancer in Scotland.
For the treatment of breast cancer, olaparib was previously under NICE review in 2018. However, olaparib’s appraisal was halted owing to limited evidence submitted by AstraZeneca.
In April 2023, NICE reversed its decision against the medicine’s use following assessments of new evidence on olaparib’s effectiveness and the agreement of a commercial deal between the manufacturer and NHS England.
Commenting on the NICE recommendation, Andrew Tutt, professor of breast oncology at the Institute of Cancer Research (ICR), London and King’s College London, said: “Locally advanced or metastatic HER2-negative breast cancer remains a devastating diagnosis.
“For those with this form of breast cancer and with inherited BRCA-mutations, the OlympiAD phase III trial demonstrated how olaparib can significantly delay cancer progression or death compared to standard chemotherapies.
“These results underpinned this positive NICE recommendation, which now provides another important oral targeted therapy option for our patients with this challenging diagnosis. This emphasises the importance of accessing genetic testing, so that these targeted drugs can reach the patients who will benefit from them,” he added.
The OlympiAD trial, published on 10 August 2017, in The New England Journal of Medicine, analysed data from 302 patients who were randomly assigned to receive olaparib or standard therapy — capecitabine, eribulin mesylate or vinorelbine — for treatment of metastatic breast cancer with a germline BRCA mutation.
The results showed that monotherapy with olaparib provided significant benefit with 2.8 months longer median progression-free survival and a 42% lower risk of disease progression or death, compared with standard therapy.
Commenting on the recommendation, Hattie Brooks, research information manager at Cancer Research UK, said: “This guidance from NICE is good news. Evidence suggests that in people with BRCA mutations who have HER2-negative advanced or metastatic breast cancer, olaparib is more effective at stopping cancer progression than chemotherapy.
“While we need more evidence to confirm how this drug compares to existing therapies, it’s promising to see new treatment strategies for this disease.”
Kristian Helin, chief executive of ICR London, said: “Olaparib was the first cancer drug in the world to target an inherited genetic fault, and I am pleased that today’s announcement means that more patients will be able to access it on the NHS.
“Following the earlier recommendation for olaparib to treat early breast cancer, patients with advanced or metastatic breast cancer, who are in desperate need of better treatment options, will now be able to receive the targeted therapy.”
The final guidance is expected to be published on 5 February 2025.
