Infinzi and Lynparza get the okay just a few months after US FDA approvals.
The Japanese Ministry of Health, Labor and Welfare is taking action to increase the availability of modern drugs for patients in the country. Two recent fast-track approvals from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) reflect the urgency driving the Ministry. Lynparza (olaparib) and Imfinzi (durvalumab), both from AztraZeneca, are two new cancer medications that only received approval from the US Food and Drug Administration within the last several months.
Lynparza, which is co-marketed by AstraZeneca and Merck & Co. (MSD outside of North America), is an oral medication for the treatment of patients with unresectable or recurrent BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 (HER2) negative breast cancer who have received prior chemotherapy. It was the first PARP inhibitor approved in Japan for the maintenance treatment of ovarian cancer earlier in 2018. AstraZeneca and Merck were set to begin marketing Lynparza in Japan for breast cancer as of July 1, 2018.
Imfinizi, which received FDA approval for the treatment of stage III lung cancer in February 2018 and has yet to be approved in the European Union, was approved in Japan for as a maintenance therapy after definitive chemoradiation therapy (CRT) in locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC), which is a leading cause of death in Japan. Imfinizi is the only immunotherapy approved in the curative-intent, Stage III lung cancer setting, according to Dave Fredrickson, executive vice president and head of AZ’s Oncology Business Unit.
