Lynparza approved in Scotland for BRCA-mutated breast cancer patients

Treatment expands options for HER2-negative metastatic breast cancer

AstraZeneca announced that its drug Lynparza (olaparib) has been approved for use in Scotland.

The approval by the Scottish Medicines Consortium (SMC) is for treating adults with HER2-negative, locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations after chemotherapy.

Breast cancer is the most common cancer among women in Scotland, with nearly 5,000 new cases diagnosed annually.

Around 5-10% of women with breast cancer carry a germline altered gene, including BRCA1 and BRCA2. In the Scottish Northern Isles of Orkney and Shetland, just two gene variants account for over 90% of inherited cancer risk from BRCA variants.

Professor David Cameron from Edinburgh University said: “Metastatic breast cancer is a challenging diagnosis. Olaparib offers a treatment option with data from the OlympiAD phase 3 trial demonstrating a significant delay in cancer progression or death compared to standard chemotherapies and to do so as a tablet therapy.

“This recommendation by the SMC represents a significant milestone for patients in Scotland, addressing an unmet need for targeted therapies for those living with BRCA-mutated HER2-negative breast cancer.”

The decision was based on results from the OlympiAD phase 3 trial. The trial showed a 42% reduction in the risk of disease worsening or death in patients treated with olaparib compared to those who received chemotherapy. The safety profile of olaparib was consistent with its known safety profile.

Tom Keith-Roach, President, AstraZeneca UK, said: “This is a significant step forward for Scottish breast cancer patients with germline BRCA-mutations. We look forward to NHS Scotland expanding BRCA gene testing eligibility to this patient group.”

Olaparib, a PARP inhibitor, disrupts the DNA-repair process to potentially kill tumour cells. The most common adverse reactions included nausea, anaemia and fatigue.