9 July 2018 - - Cambridge, England-based research pharmaceutical company AstraZenica and Kenilworth, New Jersey-based global healthcare solutions provider Merck (NYSE: MRK), known as MSD outside of the US and Canada, have received approval by Japan's Pharmaceuticals and Medical Devices Agency for Lynparza (olaparib) tablets for use in patients with unresectable or recurrent BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 -negative breast cancer who have received prior chemotherapy, the companies said.
The approval is based on data from the randomized, open-label, phase 3 OlympiAD trial, which tested Lynparza versus chemotherapy in patients with a confirmed BRCA mutation. Lynparza was found to significantly prolong progression-free survival compared with chemotherapy, reducing the risk of disease progression or death by 42%.
Lynparza, a first-in-class PARP inhibitor, potentially exploits DNA damage response pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Specifically, in vitro studies have shown that Lynparza-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes, resulting in DNA damage and cancer cell death.
AstraZenica believes that the future of treatment for many diseases lies in uncovering mechanisms that are newly emerging or are still to be discovered. The company is focused on breakthrough science to discover these mechanisms and develop novel, targeted therapies that interact with them.
Merck provides healthcare solutions worldwide through four segments: pharmaceutical, animal health, healthcare services, and alliances. The company serves drug wholesalers and retailers, hospitals, government agencies and entities, physicians, physician distributors, veterinarians, distributors, animal producers, and managed health care providers.