Breakthrough designation for AZ's Lynparza in CRPC
AstraZeneca plc (LSE:AZN; NYSE:AZN) said FDA granted breakthrough therapy designation to Lynparza olaparib as monotherapy to treat metastatic castration-resistant prostate cancer. The designation covers CRPC patients with BRCA or ataxia telangiectasia mutated (ATM) mutations who have received prior taxane-based chemotherapy and either Zytiga abiraterone or Xtandi enzalutamide.
In October, the New England Journal of Medicine published data from the Phase II TOPARP-A study evaluating Lynparza, a poly(ADP-ribose) polymerase ( PARP) inhibitor, for CRPC. Among 16 evaluable patients with mutations in DNA repair genes, 14 responded to the drug, representing a significantly higher response rate than those without mutations (see BioCentury Extra, Oct. 28, 2015). ...