AstraZeneca announced Monday that regulators in Japan approved Imfinzi (durvalumab) for certain patients with locally advanced, unresectable non-small-cell lung cancer, as well as Lynparza (olaparib) in women with unresectable or recurrent BRCA-mutated, HER2-negative breast cancer.
Specifically, the Japanese Ministry of Health, Labour and Welfare authorised Imfinzi as maintenance therapy after definitive chemoradiation therapy in locally advanced, unresectable NSCLC. Dave Fredrickson, head of the company's oncology business unit, noted that the PD-L1 inhibitor is "the only immunotherapy approved in the curative-intent, Stage III lung cancer setting."
Approval of Imfinzi was supported by data from the Phase III PACIFIC trial, with results showing that the therapy significantly prolonged progression-free survival versus placebo in patients with Stage III NSCLC. Meanwhile, new findings disclosed in May showed that Imfinzi significantly improved overall survival in the study.
The therapy has been cleared in several markets for the same indication, including the US and Canada, while a decision regarding approval in Europe is anticipated in the second half of this year. Sales of Imfinzi in the first quarter reached $62 million (for related analysis, see ViewPoints: Imfinzi’s niche-buster status gaining momentum).
Meanwhile, Lynparza, which is partnered with Merck & Co., gained clearance from Japan's Pharmaceuticals and Medical Devices Agency for use in patients with unresectable or recurrent BRCA-mutated, HER2-negative breast cancer who have received prior chemotherapy. The PARP inhibitor was approved in Japan earlier this year as maintenance treatment for women with platinum-sensitive relapsed ovarian cancer, regardless of BRCA mutation status.
Clearance of Lynparza in breast cancer was backed by safety and efficacy data from the late-stage OlympiAD trial. In the study, the results of which were released in 2017, the drug was found to lower the risk of death or progression by 42 percent compared to chemotherapy.
In January, Lynparza was approved in the US for the treatment of patients with BRCA-mutated metastatic breast cancer, while a filing in this indication was accepted by the European Medicines Agency last month. In the first quarter, sales of Lynparza more than doubled to $119 million. For related analysis, read ViewPoints: AstraZeneca, Merck & Co. pass first test to move Lynparza into first-line ovarian cancer patients.
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