Japanese approval for AstraZeneca Lynparza and Imfinzi

There was good news for Anglo-Swedish pharma major AstraZeneca (LSE: AZN) and its partners, with fast-track approval from Japan’s regulator for their breast cancer and lung cancer drugs.

First up, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved Lynparza (olaparib) tablets for use in patients with unresectable or recurrent BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 (HER2) negative breast cancer who have received prior chemotherapy. Patients are selected for therapy based on an approved companion diagnostic. Lynparza is co-marketed with US pharma giant Merck & Co (NYSE: MRK), known as MSD outside of North America.

Dave Fredrickson, executive vice president, head of the Oncology Business Unit at AstraZeneca, said: “Earlier this year, Lynparza became the first PARP inhibitor available in Japan for advanced ovarian cancer. Now patients in Japan with BRCA-mutated, metastatic breast cancer will also have the opportunity to benefit from Lynparza. This latest approval underlines our ongoing efforts to make Lynparza available across multiple cancers as quickly as possible to patients around the world.”