Positive NICE recommendation for BRCAm ovarian cancer

AstraZeneca UK announced that Lynparza (olaparib) is recommended by the National Institute for Health and Care Excellence (NICE) for maintenance treatment of BRCA-mutated relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who have had two or more courses of platinum-based chemotherapy. BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role maintaining the genetic stability of cells.1 Women who inherit a fault in the BRCA1 or BRCA2 gene, for example, have a 36-53% risk of ovarian cancer before the age of 80.2 The decision by NICE is based on evidence from the SOLO-2 Phase III Clinical trial, published in The Lancet Oncology which demonstrated a significant improvement in progression-free survival (PFS) in BRCAm, platinum-sensitive, relapsed ovarian cancer patients treated with olaparib tablets (300mg twice daily) compared with placebo in the maintenance. Why is this NICE FAD for olaparib significant? Ovarian cancer represents a significant unmet need in gynaecological cancers.3 Ovarian cancer has the highest mortality of all female reproductive cancers,1 largely owing to the absence of early symptoms and lack of effective screening, resulting in diagnosis at an advanced stage.4 While survival rates have improved in recent years,5 they still lag behind those for other cancers and over 4,000 women die of the disease in the UK every year.6 In overview, 7,500 women are diagnosed with ovarian cancer every year or 21 per day, ovarian cancer is the sixth most common cancer in the UK, and incidence rates for ovarian cancer are projected to rise by 5% in the UK by 2040.7 There could be around 9,400 new cases of ovarian cancer every year in the UK by 2038-2040, projections suggest.7 Official comment Tom Keith-Roach, President, AstraZeneca UK, said: “Olaparib was discovered and developed in the UK, which makes today’s positive recommendation for BRCA-mutated platinum-sensitive relapsed, high-grade epithelial ovarian cancer patients in the UK even more significant. AstraZeneca has a bold ambition to provide hope for patients with cancer. This requires continued investment and greater access to new innovations, and today’s news is another positive step.” David Long, Head of Oncology at MSD UK said: “BRCA-mutated platinum-sensitive, relapsed ovarian cancer can be a devastating diagnosis for patients and their families as it often has a poor prognosis. This recommendation is an important milestone in advancing cancer care in the UK. We are optimistic that this treatment option may help improve outcomes for patients.” References National Cancer Institute. BRCA Gene Mutations: Cancer Risk and Genetic Testing. Available at: https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet#:~:textBRCA1%20(BReast%20CAncer%20gene%201,copy%20inherited%20from%20each%20parent. Last accessed: June 2023. NHS. Predictive genetic tests for cancer risk genes. Available at: https://www.nhs.uk/conditions/predictive-genetic-tests-cancer/. Last accessed: June 2023. Guarneri V, et al. Achievements and unmet needs in the management of advanced ovarian cancer. Gynaecol Oncol. 2010;117(2):152-8. Walker M, et al. Management of ovarian cancer risk in women with BRCA1/2 pathogenic variants. CMAJ. 2019;191(32):E886-E893. Cancer Research UK. Ovarian cancer survival statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/ovarian-cancer/survival. Last accessed: June 2023. Cancer Research UK. Ovarian cancer mortality statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/ovarian-cancer/mortality. Last accessed: June 2023. Cancer Research UK. Ovarian cancer statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/ovarian-cancer#heading-Zero. Last accessed: June 2023.