CHMP recommends approval of Lynparza as a single-drug therapy for adult patients with breast cancer

, thegiant apharmaceutical(http:// and partner Merck and Co announced inthat the European(http://Authorityproducts for human medicine(http:// http://Committee (CHMP) has issued a positive opinion recommending the approval of Lynparza (Chinese brand name: Lipdro, generic name: olaparib, Olapari tablets), as a single-drug therapy for the treatment of BRCA1/2 mutations in the reproductive system, Human epidermal growth factor receptor 2 (HER2-) negative, localized advanced or metastatic breast cancer adult patientsLynparzaLynparza is a pioneering oral PARP inhibitor that prioritizes the use of defects in DNA repair pathways to kill cancer cells, a model that gives the drug 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 was approved in December 2014 as the world's first PARP inhibitorTo date, the drug has also been approved by more than 60 countries worldwide for platinum-sensitive recurrent ovarian cancer, regardless of BRCA statusin the United States, Lynparza was again approved at the end of 2018 for the maintenance of BRCAm advanced ovarian cancer, which is reactive after first-line platinum chemotherapyIn addition, the drug has been approved by the United States, Canada, Japan, Australia for her2-negative metastatic breast cancer with BRCA mutation 　　CHMP's positive opinion, based on data from the Phase III Olympus Study This is a random, open label, multicenter study conducted in 302 patients with HER2 negative metastatic breast cancer that was identified as harmful or suspected to be harmful to the reproductive line BRCA1 or BRCA2 mutations, and evaluated the efficacy and safety of Lynparza (300mg, 2 times a day) relative to the selected doctor's standard nursing chemotherapy (Carpetabin, Changchun Ruibin, Ayzhbrin) 　　The results showed that the Lynparza treatment group achieved a statistically significant extension of progression and clinical significance (median PFS: 7.0 months vs 4.2 months; HR : 0.58; 95% CI: 0.43-0.80; p -0.0009) achieved a significant reduction in the overall endpoint compared to the standard chemotherapy group On the secondary endpoint, the duration of death in the Lynparza treatment group deteriorated again (PFS2) by a 1x increase (ORR: 59.9% vs 28.8%) compared to the standard chemotherapy group( HR: 0.57, 95% CI: 0.40-0.83) the study, no new security signals from Lynparza were observed, and the overall safety was consistent with previous studies In terms of level 3 and higher adverse events, the Lynparza treatment group was lower than the chemotherapy group (36.6% vs 50.5%) In terms of treatment interruption rates, lynparza was also lower in the treatment group than chemotherapy (4.9 percent vs 7.7 percent) The most common adverse events were nausea (50.2%), anemia (32.2%) and fatigue (22.4%)