On December 19, 2018, AstraZeneca and Merck jointly announced that the US Food and Drug Administration (FDA) has approved Olapa for the use of harmful or suspected harmful germline or somatic BRCA mutations (gBRCAm or sBRCAm) in advanced epithelium. Adult patients with ovarian cancer, fallopian tube cancer or primary peritoneal cancer who have achieved first-line maintenance therapy after complete or partial remission after receiving first-line platinum chemotherapy. These patients require prior FDA-approved companion diagnostic tests. Olapali became the first PARP inhibitor approved for first-line maintenance therapy for BRCA-mutant advanced ovarian cancer. This approval is based on the positive results of the critical phase III SOLO-1 trial. The trials confirmed that olapacal reduced the risk of disease progression or death by 70% compared with placebo in patients with advanced ovarian cancer with BRCA mutations who achieved complete or partial remission after platinum-based chemotherapy (HR 0. 30 [95% CI 0.23-0.41], p <0.0001). Olapali's safety data is consistent with previous trials. <> Dave Fredrickson, executive vice president of AstraZeneca's oncology business, said: "Ovarian cancer patients are often at advanced stage of diagnosis and have a poor prognosis. The results of the SOLO-1 trial indicate that olaapril can mutate BRCA as first-line maintenance therapy. The risk of disease progression or death in patients with advanced ovarian cancer is reduced by 70%. Today's approval is a major advancement that will allow us to get closer to the goal of helping these patients achieve long-term relief from disease." Roy Baynes, chief medical officer, senior vice president and global clinical development director at Merck Research Laboratories, said: "Based on the results of the SOLO-1 trial, Olapali is again gaining new approvals, which is expected to change medical practices and further improve To understand the importance of the status of the female BRCA gene at the time of diagnosis, we will continue to work with AstraZeneca to improve the treatment of patients." In the SOLO-1 trial, the median value of progression-free survival (PFS) was not achieved in the olaapali group after a median 41-month follow-up, compared with a median PFS of 13.8 months in the placebo group. In the Olapali group, 60% of patients had no disease progression within 3 years, compared with 27% of the placebo group. Data on the SOLO-1 trial has been published online October 21, 2018 in the New England Journal of Medicine. Kathleen Moore, deputy director of clinical research at the Stephenson Cancer Center, University of Oklahoma, Okla., said: "SOLO-1 is a truly landmark gynecologic oncology trial. This approval May alter the way we treat patients with advanced ovarian cancer with BRCA mutations. By providing this important first-line maintenance treatment to eligible patients, we are expected to slow or even halt the natural progression of disease progression." SOLO-1 is a phase III randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate olaipril tablets (300 mg twice daily) as a single-agent maintenance therapy compared with placebo. Efficacy and safety of patients with advanced ovarian disease with BRCA mutations who received first-line platinum chemotherapy. The trial randomized 391 patients with harmful or suspected harmful germline or somatic BRCA1 or BRCA2 mutations who achieved complete or partial remission after receiving platinum-based chemotherapy. Patients were randomized (2:1 ratio) to olapac or placebo for two years or until disease progression. For patients with partial remission after two years, the researchers decide whether they are allowed to continue treatment. The primary end point was progression-free survival, and the key secondary endpoints included the time to the second occurrence of disease progression or death, the time to the first follow-up treatment, and the overall survival. Olapali is a first-class PARP inhibitor and the first targeted therapy that potentially uses DNA damage response (DDR) pathway defects (such as BRCA mutations) to preferentially kill cancer cells. Inhibition of PARP by the use of olpalyl will result in the failure of DNA single-strand breaks to be repaired, while the replication fork stagnates and collapses, eventually leading to DNA double-strand breaks and cancer cell death. Olapali is testing a range of DDR-deficient and DDR-dependent tumors. Olapali, developed and commercialized by AstraZeneca and Merck, is currently approved for the treatment of advanced ovarian and metastatic breast cancer and is used in more than 20,000 patients worldwide. Olapali has the most extensive and advanced clinical trial development program for PARP inhibitors. AstraZeneca and Merck are working together on how to use olalapril alone for multiple PARP-dependent tumors, as well as combination therapies for multiple cancer types. Based on Olapali, AstraZeneca has gained the industry's leading position in the field of potential new drug development for targeting cancer cell DDR mechanisms. dental handpiece,dental handpiece high speed,handpiece dental,dental high speed handpiece,dental laboratory handpiece Foshan Ja Suo Medical Device Co., LTD , https://www.jasuodental.com