FDA grants priority to olaparib

Source: AstraZeneca announced on May 1, 2014, that FDA has granted the priority qualification for new drug application (NDA) of olaparib Olaparib is an innovative oral poly ADP ribose polymerase (PARP) inhibitor, which takes advantage of defects in DNA repair pathway to preferentially kill cancer cells Currently, AstraZeneca is investigating the use of olaparib in the treatment of BRCA mutant ovarian cancer If approved, olaparib will become the first PARP inhibitor for BRCA mutant platinum sensitive recurrent ovarian cancer Olaparib NDA's submission is based on data from phase II study-19 Study-19, a randomized, double-blind, placebo-controlled phase II study, was conducted in patients with platinum sensitive recurrent serous ovarian cancer who had previously received at least two platinum chemotherapy regimens and were in partial or complete remission after the last platinum chemotherapy The efficacy and safety of olaparib 400mg bid (twice a day) as a maintenance therapy were evaluated The primary end point of the study was disease progression free survival (PFS) The secondary end point included the time of cancer recurrence, total survival and safety In addition, the European Drug Administration (EMA) received a review of olaparib's marketing approval application (MAA) in September 2013 At the same time, AstraZeneca launched olaparib's phase III solo project in September 2013 to investigate the PFS benefits of olaparib as a single drug therapy for the maintenance treatment of patients with BRCA mutant platinum sensitive ovarian cancer The initiation of phase III solo project is based on the results of subgroup analysis of BRCA mutation in patients with recurrent ovarian cancer in phase II maintenance study Relevant data have been submitted to the 2013 meeting of American Society of Clinical Oncology (ASCO), which proves that olaparib is a single drug therapy for carrying BRCA The potential of maintenance therapy in patients with mutant platinum sensitive recurrent ovarian cancer Subgroup analysis identified that ovarian cancer patients with BRCA mutation obtained the greatest therapeutic benefit from olaparib single drug maintenance therapy Compared with placebo, olaparib significantly prolonged the progression free survival (PFS) of ovarian cancer patients with BRCA mutation (11.2 months vs 4.3 months, HR 0.18; 95% CI 0.11-0.31; P < 0.00001) The findings highlight the growing focus on the nature of anticancer drug development, that is, gene profiles for specific subgroups of patients.