The European Medicines Agency has accepted AstraZeneca’s marketing authorisation application for olaparib as a treatment for certain ovarian cancer patients.
Specifically, the regulator will look at olaparib, an investigational poly ADP-ribose polymerase (PARP) inhibitor for the maintenance treatment of patients with BRCA mutated platinum-sensitive relapsed serous ovarian cancer. The filing is based on a Phase II study which evaluated maintenance treatment with olaparib 400mg twice daily versus placebo; a subgroup analysis was conducted of patients who have BRCA mutations (136 of them), which showed treatment benefit.
AstraZeneca said that olaparib has the potential to be the first PARP inhibitor available for the latter set of patients. The file represents a turnaround in the fortunes of the PARP inhibitor, given that the company decided, in December 2011, not to progress olaparib into Phase III, a decision which was reversed earlier this month.
Meantime, AstraZeneca noted that the EMA has accepted its file for naloxegol, for the treatment of opioid-induced constipation in adults with chronic non-cancer pain.
The drug, licensed from Nektar Therapeutics, is a peripherally-acting mu-opioid receptor antagonist.
