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CHMP okays AstraZeneca's Lynparza for BRCA-mutated platinum sensitive relapsed ovarian cancer
24 October 2014 - 24 October 2014 - Anglo-Swedish AstraZeneca (LON:AZN) said Friday that Lynparza (olaparib) had received recommendation for approval from the European Committee for Medicinal Products for Human Use (CHMP) as a maintenance therapy of adults with platinum sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Olaparib, a poly ADP-ribose polymerase (PARP) inhibitor, exploits tumour DNA repair pathway deficiencies to specifically destroy cancer cells.

The recommendation was given considering data from a Phase II study that assessed the efficacy and safety of olaparib versus placebo in women with platinum sensitive relapsed high grade serous ovarian cancer. The results demonstrated that maintenance treatment with olaparib markedly extended  progression free survival (PFS) versus placebo in patients with BRCA-mutated ovarian cancer, namely median PFS 11.2 months versus 4.3 months (PFS HR=0.18; 95% CI 0.10–0.31; p
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