2nd Jul 2018 08:12
LONDON (Alliance News) - AstraZeneca PLC said Monday it got two new approvals in Japan for the use of PARB inhibitor Lynparza in breast cancer and lung cancer immunotherapy Imfinzi.
The FTSE 100-listed pharmaceutical giant said Japan's Pharmaceuticals and Medical Devices Agency approved Lynparza tablets for use in patients with BRCA-mutated human epidermal growth factor receptor 2 negative breast cancer.
BRCA mutations makes cells more unstable and increase the likelihood of developing cancer, the company explained.
The approval follows Lynparza's previous one in Japan as a treatment for ovarian cancer.
Head of the oncology business unit Dave Fredrickson 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."
In a separate announcement, AstraZeneca said the that the Japanese Ministry of Health, Labour and Welfare approved Imfinzi as a maintenance therapy after definitive chemoradiation therapy in locally-advanced unresectable non-small cell lung cancer.
"Non-small cell lung cancer is a leading cause of death in Japan, and we are dedicated to bringing new treatment options to patients as quickly as possible. As the only immunotherapy approved in the curative-intent, Stage III lung cancer setting, Imfinzi has the potential to change the treatment paradigm for patients diagnosed with this disease," Fredrickson added.
AstraZeneca shares were trading down 0.8% at 5,213.00 pence early Monday morning.
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