AstraZeneca's starts olaparib in Ph III for ovarian cancer

4 September 2013

Anglo-Swedish drug major AstraZeneca (LSE: AZN) says it has enrolled the first patient in the Phase III clinical program for olaparib, an innovative oral poly ADP ribose polymerase (PARP) inhibitor being investigated for the treatment of BRCA mutated ovarian cancer, on which the company stopped development a couple of years ago (The Pharma Letter December 21, 2011).

Earlier this year, having re-evaluated Phase II data with the drug, the company decided to move into Phase III testing and said it had submitted a Letter of Intent to file for approval with the European Medicines Agency for olaparib in ovarian cancer patients with BRCA mutations (TPL June 3).

The Phase III SOLO (Study of OLaparib in Ovarian cancer) programme is designed to determine the benefit, by progression free survival, of olaparib as a maintenance monotherapy in BRCA mutated ovarian cancer patients who are in complete or partial response following platinum-based chemotherapy in the first line setting (SOLO 1), and in the relapsed setting (SOLO 2).

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