Thursday, June 6, 2013

Kyowa Hakko Kirin files 5-FU for approval in Japan for the treatment of Pancreatic cancer

Kyowa Hakko Kirin has filed an application to Japan's Ministry of Health, Labour and Welfare ("MHLW") seeking approval for additional dosage and administration for pancreatic cancer of 5-FU Injection 250mg and 1000mg (generic name: Fluorouracil, "5-FU"). This application is based on the results of a Phase II/III study conducted in France which is known as the ACCORD 11 study and a Phase II study conducted by Yakult Honsha Co., Ltd. in Japan regarding FOLFIRINOX regimen for patients of metastatic pancreatic cancer which had not been previously treated with chemotherapy.

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