BioCentury
ARTICLE | Clinical News

Lynparza olaparib regulatory update

February 1, 2016 8:00 AM UTC

FDA granted breakthrough therapy designation to Lynparza olaparib from AstraZeneca as monotherapy to treat metastatic castration-resistant prostate cancer (CRPC). The designation covers patients with BRCA or ataxia telangiectasia mutated (ATM) mutations who have received prior taxane-based chemotherapy and either Zytiga abiraterone or Xtandi enzalutamide. AZ markets Lynparza to treat BRCA-mutated ovarian cancer. ...