FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Japan Clears First Drug to Treat Merkel Cell Carcinoma

Oct. 2, 2017

Japan’s Ministry of Health, Labor and Welfare approved its first treatment for Merkel cell carcinoma.

Merck’s Bavencio (avelumab) is already approved for use in Europe and the U.S. This is the drug’s fifth approval in 2017 and the first in an Asian market.

MCC is a designated rare disease in Japan, affecting an estimated fewer than 100 patients, which led to the drug’s orphan drug designation last December.

The agency based the approval on data from an international, multi-center Phase II study, the largest ever registrational clinical trial for an immunotherapy in metastatic MCC.

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