AstraZeneca and Merck Seeking Lynparza Approval in Japan for Certain Breast Cancer Patients

AstraZeneca and Merck Seeking Lynparza Approval in Japan for Certain Breast Cancer Patients
AstraZeneca and Merck submitted a new drug application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) seeking the approval of Lynparza (olaparib) tablets for the treatment of patients with unresectable or recurrent BRCA-mutated breast cancer. A decision by the agency is expected by the end of 2018. This is the second new drug application for Lynparza submitted to the Japanese regulatory agency, which is currently reviewing the drug as an ovarian cancer treatment. AstraZeneca and Merck also filed an application with the U.S. Food and Drug Administration earlier this month, requesting Lyparza approval for a similar breast cancer indication. The submissions were based on data from the OlympiAD Phase 3 trial (NCT02000622), where Lynparza was shown to significantly delay cancer progression in HER2-negative, BRCA-mutated metastatic breast cancer patients, compared to standard chemotherapy. The results were recently published in The New England Journal of Medicine in the study, “Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation.” Lynparza, an oral PARP inhibitor, is already approved by the FDA for patients with recurrent ovarian cancer whose tumors carry a mutatio
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