AstraZeneca, Mersadon jointly announce PARP inhibitor Olapari expected to be approved by the end of the year

Pancreatic cancer, known as the "King of Cancer", is one of the deadliest types of cancer, with a five-year survival rate of less than 7%, and 80% of patients have metastasized by the time they are diagnosedOlapari was the first approved PARP inhibitor and the first targeted therapy for DNA damage repair (DDR) pathway defects such as BRCA gene mutationsAs two important DNA repair proteins in cells, PARP primarily repairs single-stranddamage in DNA, while BRCA primarily repairs double-stranded damage in DNAIn cancer patients with BRCA1 or BRCA2 mutations, DNA damage repair becomes very dependent on PARP due to inactivation of the BRCA proteinIf PARP activity is further inhibited, tumor cells can cause a large number of DNA damage when they divide, eventually leading to their deathPARP inhibitors not only have significant results in breast and ovarian cancer patients with BRCA mutations, but have also been significantly effective in prostate cancer patients who carry BRCA mutationsin China, Olapari has become the only PARP inhibitor approved for first-line maintenance treatment for ovarian cancerIt has also been successfully included in the 2019 National Health Insurance List for Class B drugs for the maintenance treatment of platinum-sensitive recurrent ovarian cancer, whether or not it carries a BRCA gene mutationin July this year, published in the New England Journal of Medicine (NEJM), the results of a randomized double-blind, postbobono-controlled Phase 3 clinical trial POLO showed that, compared to the placebo group, Olapali was able to increase the patient's progressionless survival (PFS) from 3.8 months to 7.4 months (HR: 0.53, 95% CI, 0.35-0.82, p.0004) compared to the placebo groupHowever, a mid-term analysis of total lifetime (OS) showed that the median OS in the Olapari group was 18.9 months, with no statistically significant difference compared to the placebo group (18.1 months)These metastatic pancreatic cancer patients carry mutations in the brca1 or BRCA2 gene of the reproductive line, and the disease did not progress after first-line platinum-based chemotherapy"The ODAC's recommendation for Lynparza is encouraging," said DrJos? Baselga, executive vice president of research and development for AstraZeneca Oncology,of The osmoparly in Phase 3 clinical trial POLO (Photo: SuppliedIt may lead to an individualized drug targeting biomarkers in patients with metastatic pancreatic cancer that carries mutations in the BRCA gene in the reproductive systemOver the past few decades, these patients have had a poor prognosis due to the invasion of the disease and the limited progress in research and developmentWe look forward to working with the FDA to complete the review of this applicationReferences:, LYNPARZA ® (olaparib) Recommended by FDA Advisory Committee for First-Line Maintenance Therapy in Germline BRCA-Statea Meta Center Cancer Has Has Not Progressed on Platinum-AddyRetrieved December 17, 2019, from https://Maintenance Olaparib for Germline BRCA-Administration Metastatic Sastatic CancerThe New England Journal of Medicine of Medicine, DOI: 10.1056/NEJMoa1903387original title: CourierPARP inhibitor Olapari is supported by FDA advisory board and is expected to be approved for treatment of pancreatic cancer patients by the end of the year