AstraZeneca PARP inhibitor Lynparza (olaparib) approved by the European Commission

yesterday (June 18), AstraZeneca announced that its PARP inhibitor Lynparza (olaparib) has been approved by the European Commission as a first-line maintenance therapy for patients with advanced ovarian cancer with BRCA mutationsAbout Lynparza
Lynparza is the world's first PARP inhibitor, and in December 2014 it was first approved by the U.SFDA(http://approved for advanced ovarian cancer patients carrying harmful or suspected harmful type BRCA mutations (gBRCAm)To date, 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 BRCA mutationsin China, Lynparza was approved by the State Drug Administration in August 2018 for the maintenance of platinum-sensitive recurrent ovarian cancer, and is the first targeted drug approved for ovarian cancer treatment in China, which is of great significance to the treatment of ovarian cancer in ChinaFor the SOLO-1 study
this approval is based on the results of a critical Phase III clinical study SOLO-1, a Phase III, randomized, double-blind, placebo-controlled, multicentertrial(http://, evaluating the efficacy and safety of Lynparza tablets (twice a day) as a maintenance monodotherapy and placebo treatment for patients with late-stage ovarian cancer in BRCAmresults showed a statistically significant and clinically significant improvement in the Lynparza treatment group compared to the placebo group, reducing the risk of disease progression or death by 70% (HR?0.30?95%-CI-0.23-0.41,p.001)After 41 months of follow-up, the pfS in the Lynparza treatment group did not reach, and the placebo group was 13.8 monthsSixty percent of patients in the Lynparza treatment group did not progress within 36 months of treatment, compared with 27 percent in the placebo groupIn terms of security
SOLO-1 is consistent with previous studiesThe most common adverse events (AEs) were nausea (77%), fatigue (63%), vomiting (40%), anemia (39%) and diarrhea (34%)based on THE SOLO-1 findings, Lynparza received FDA approval in December 2018 for the first-line maintenance treatment of BRCAm advanced ovarian cancer