AstraZeneca and Merck & Co., Inc., Kenilworth, New Jersey, US (known as MSD outside the US and Canada) announced that they have submitted a new drug application (NDA) to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the use of Lynparza (olaparib) tablets in unresectable or recurrent BRCA-mutated breast cancer, with a decision expected in the second half of 2018.
The Japan NDA is based on the positive results from the phase III OlympiAD trial published in the New England Journal of Medicine.
This is the second NDA for Lynparza in Japan where the medicine is currently under review for use in ovarian cancer, with a PMDA decision for this indication anticipated in the first half of 2018.
Lynparza tablets are currently being tested in a range of tumour types in addition to ovarian and breast, including prostate and pancreatic cancers.