FDA approves Lynparza as a maintenance therapy for patients with advanced ovarian cancer with BRCA mutation (BRCAm)

recently, http://giant AstraZeneca, the uk'spharmaceutical(http:// and partner Merck and Co announced that the u.SFood andDrug(http://Authority (
FDA(http://) had approved Lynparza (Lipjo, olaparib, Olapari tablets) as a maintenance therapy for first-line platinum-containing chemotherapy patientsLynparzaLynparza is a pioneering, oral PARP inhibitor that prioritizes the use of defects in DNA repair pathways to kill cancer cells, a mode of action that gives Lynparza the potential to treat a wide range of types of tumors with DNA repair defectsPARP is associated with a wide range of tumor types, especially breast and ovarian cancerLynparza, the world's first PARP inhibitor, was first approved by the U.SFDA in December 2014 for advanced ovarian cancer patients with a harmful or suspected harmful type of BRCA mutation (gBRCAm)So far, Lynparza has been approved for platinum-sensitive recurrent ovarian cancer (regardless of BRCA status) in more than 60 countries around the world, and the drug has been approved by the United States, Canada, Japan, and Australia for HER2-negative metastatic breast cancer with a BRCA mutation related studies
this approval is based on the results of the critical Phase III clinical study SOLO-1 The results showed that Lynparza achieved a statistically significant and clinically significant improvement in progressionless (PFS) compared to placebo, reduced the risk of disease progression or death by 70% (HR?0.30.30.25%CI-0.23-0.41), p.001) follow-up for 41 months, the level PFS in the Lynparza treatment group was not yet reached, and the placebo group was 13.8 months Sixty percent of patients in the Lynparza treatment group did not progress within 36 months of treatment, compared with 27 percent in the placebo group In this study, Lynparza's safety characteristics were consistent with previous studies AstraZeneca and Mersadon reached a global strategic partnership for oncology in July 2017 to jointly develop and commercialize Lynparza and another MEK inhibitor, selumetinib, for the treatment of a wide range of tumors Currently, the two sides are conducting several clinical studies to investigate the potential of Lynparza for a wide range of types of tumors, including breast, prostate and pancreatic cancers in the Chinese market, Lynparza was approved by China's National Drug (http:// Regulatory Authority (CNDA) on August 23 this year for the maintenance of platinum-sensitive recurrent ovarian cancer