Olaparib: first global approval

Drugs. 2015 Feb;75(2):231-40. doi: 10.1007/s40265-015-0345-6.


Olaparib (Lynparza™) is an oral, small molecule, poly (ADP-ribose) polymerase inhibitor being developed by AstraZeneca for the treatment of solid tumours. The primary indication that olaparib is being developed for is BRCA mutation-positive ovarian cancer. A capsule formulation of the drug has received approval for use in this setting in the EU and USA, and a tablet formulation is in global phase III trials (including in the USA, EU, Australia, Brazil, Canada, China, Israel, Japan, Russia and South Korea). In addition, phase III trials in breast, gastric and pancreatic cancer are underway/planned, and phase I/II investigation is being conducted in other malignancies, including prostate cancer, non-small cell lung cancer, Ewing's sarcoma and advanced cancer. This article summarizes the milestones in the development of olaparib leading to this first approval for ovarian cancer.

Publication types

  • Review

MeSH terms

  • Administration, Oral
  • Animals
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / pharmacology
  • Antineoplastic Agents / therapeutic use*
  • BRCA1 Protein / antagonists & inhibitors
  • BRCA1 Protein / genetics
  • BRCA2 Protein / antagonists & inhibitors
  • BRCA2 Protein / genetics
  • Clinical Trials, Phase III as Topic
  • Drug Approval*
  • Female
  • Humans
  • Molecular Structure
  • Mutation
  • Ovarian Neoplasms / drug therapy*
  • Ovarian Neoplasms / genetics
  • Phthalazines / administration & dosage
  • Phthalazines / pharmacology
  • Phthalazines / therapeutic use*
  • Piperazines / administration & dosage
  • Piperazines / pharmacology
  • Piperazines / therapeutic use*


  • Antineoplastic Agents
  • BRCA1 Protein
  • BRCA2 Protein
  • Phthalazines
  • Piperazines
  • olaparib