While this approval addresses breast cancer, olaparib in combination with durvalumab was approved by the EU in August 2024 for treatment of endometrial cancer.
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AstraZeneca has announced that its Lynparza (olaparib) has been accepted within NHS Scotland, that country’s healthcare system, by the Scottish Medicines Consortium (SMC) (1). The approval, according to a Feb. 10, 2025 press release from AstraZeneca, is intended for treatment of adults with human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with germline breast cancer genes 1 or 2 (BRCA1, BRCA2) mutations after chemotherapy.
“This is a significant step forward for Scottish breast cancer patients with germline BRCA-mutations,” Tom Keith-Roach, president of AstraZeneca UK, said in the press release. “We look forward to NHS Scotland expanding BRCA gene testing eligibility to this patient group.”
BRCA1 and BRCA2 produce proteins responsible for repairing damaged DNA; when these genes are mutated or altered, AstraZeneca explained in the release, cells may become unstable due to the DNA damage not being able to be repaired (1). Olaparib, according to AstraZeneca, is a product created in the United Kingdom that is a poly-ADP-ribose polymerase (PARP) inhibitor, a targeted cancer therapy that targets PARP in order to disrupt the DNA repair process and potentially kill tumor cells.
Almost 5000 people in Scotland are diagnosed with breast cancer every year, AstraZeneca said, with mutations in the BRCA genes significantly increasing cancer risk—and being found in up to 10% of breast cancer patients (1). Those who carry the mutations have a 50/50 chance of passing them to their children.
SMC’s decision on olaparib was based on positive results from a Phase III trial (OlympiAD) that met its primary endpoint of median progression-free survival, showing that patients treated with olaparib experienced a 42% reduction in risk of disease worsening or death versus those treated with chemotherapy (1). Some of the most common adverse reactions included nausea, anemia, fatigue, and vomiting.
“Metastatic breast cancer is a challenging diagnosis for patients, who have to expect shortened survival, often experiencing low health-related quality of life, and a significant burden from its treatment,” Professor David Cameron, professor of oncology at Edinburgh University and director of Cancer Services at NHS Lothian, said in the press release. “For those women whose breast cancer has arisen on a background of an inherited (germline) alteration in the BRCA1 or BRCA2 genes, olaparib offers patients a treatment option, with data from the OlympiAD Phase III 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.”
Olaparib was previously approved throughout the European Union in August 2024 in combination with another AstraZeneca product, Imfinzi (durvalumab), for another type of cancer treatment, that of certain people who have primary advanced or recurrent endometrial cancer (2).
AstraZeneca, meanwhile, has continued to make inroads outside the UK early in 2025, announcing in January that it would be creating more than 700 high-skilled jobs in Canada, specifically around the greater Toronto area, as the result of a C$820 million (US$570 million) investment (3).
1. AstraZeneca. Lynparza (olaparib) Accepted for Use in Scotland to Treat Germline BRCA-Mutated HER2-Negative Locally Advanced or Metastatic Breast Cancer After Chemotherapy. Press Release. Feb. 10, 2025.
2. AstraZeneca. Lynparza and Imfinzi Combination Approved in the EU for Patients with Mismatch Repair Proficient Advanced or Recurrent Endometrial Cancer. Press Release. Aug. 14, 2024.
3. AstraZeneca. AstraZeneca Plans C$820 million (US$570m) Investment in Canada to Advance Growing Global Hub and Clinical Delivery. Press Release. Jan. 23, 2025.
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