AstraZeneca and Merck have announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the use of Lynparza (olaparib) in platinum-sensitive, relapsed, high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer.
The CHMP opinion recommends marketing authorisation of 300mg twice-daily Lynparza tablets as a maintenance therapy for patients who are in complete or partial response to platinum-based chemotherapy.
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Lynparza is being developed as an inhibitor of a poly (ADP-ribose) polymerase (PARP) and the positive recommendation is based on findings from two randomised clinical trials, SOLO-2 and Study 19.
The data from these studies demonstrated a decreased risk of disease progression or death in platinum-sensitive relapsed patients treated with Lynparza when compared to placebo.
Merck Research Laboratories global clinical development senior-vice president and head, chief medical officer Dr Roy Baynes said: “We welcome this positive opinion based upon data which indicate the potential impact for Lynparza as maintenance therapy for women with platinum-sensitive relapsed ovarian cancer.
“We look forward to our continued work with AstraZeneca to bring Lynparza to patients in the European Union (EU).”
Lynparza has been previously approved as a capsule formulation, and the new tablet form is intended to minimise dosing from eight capsules to two tablets.
The drug is currently marketed for ovarian cancer in around 60 countries, and was approved last month by the US Food and Drug Administration (FDA) for use in patients with metastatic breast cancer.
