NICE recommends olaparib for BRCA-mutated breast cancer treatment

Groundbreaking approval provides new hope for patients in England and Wales

The National Institute for Health and Care Excellence (NICE) has given a positive recommendation for Lynparza (olaparib) for NHS use in England and Wales.

This treatment targets adults with HER2-negative, locally advanced or metastatic breast cancer who have germline BRCA1 or BRCA2 mutations, following chemotherapy.

Germline BRCA1 and BRCA2 mutations account for 5% to 10% of all breast cancers, with genetic testing being essential for optimal care.

Professor Andrew Tutt, Director of the Toby Robins Breast Cancer Now Research Centre, said: “Locally advanced or metastatic HER2-negative breast cancer remains a devastating diagnosis. For those with this form of breast cancer and inherited BRCA-mutations, the OlympiAD phase 3 trial demonstrated how olaparib can significantly delay cancer progression or death compared to standard chemotherapies.”

NICE’s decision is based on positive results from the pivotal OlympiAD phase 3 trial, which showed that olaparib significantly reduced the risk of disease worsening or death by 42%. The safety profile of olaparib was consistent with known effects.

Olaparib is a precision medicine and PARP inhibitor that disrupts the DNA-repair process in cancer cells, helping to potentially kill tumour cells. Tom Keith-Roach, President of AstraZeneca UK, said: “We are delighted that NICE has recommended olaparib. This decision is AstraZeneca’s 26th cancer medicine recommendation from NICE and the SMC since 2021.”

Testing for BRCA mutations is available and reimbursed by the NHS via the National Genomic Test Directory.

This decision emphasises the importance of genetic testing to ensure targeted drugs reach the patients who will benefit from them.