AstraZeneca and Merck & Co., Inc. announced that the Japanese Ministry of Health, Labour and Welfare has approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer, regardless of their BRCA mutation status, who responded to their last platinum-based chemotherapy. Lynparza is the first poly ADP-ribose polymerase (PARP) inhibitor to be approved in Japan. The approval was granted on the basis of two randomised trials of Lynparza maintenance therapy for platinum-sensitive relapsed ovarian cancer, SOLO-2 and Study 19.

In SOLO-2, the most common adverse drug reactions (=20%) of any grade reported in patients in the Lynparza arm were nausea (66.7%), anaemia (39.0%), fatigue (29.7%), vomiting (25.6%), asthenia (24.1%) and dysgeusia (23.1%). In Study 19, the most common adverse drug reactions (=20%) of any grade reported in patients in the Lynparza arm were nausea (64.0%), fatigue (43.4%) and vomiting (21.3%). Lynparza is also currently under review for use in unresectable or recurrent BRCA-mutated, HER2-negative breast cancer in Japan, with a decision expected in the second half of 2018 based upon a priority review.