Japanese MHLW OK’s Bayer’s cancer drug
January 20, 2017Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review to Bayer Yakuhin for regorafenib in the second-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
Regorafenib was submitted for marketing approval in HCC in Japan in October 2016. The MHLW grants priority review to medicines on the basis of their clinical usefulness and severity of the disease. Regorafenib is already approved under the brand name Stivarga in many countries, including Japan, to treat metastatic colorectal cancer and unresectable and/or metastatic gastrointestinal stromal tumors.
Dr. Joerg Moeller, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Development commented: “Liver cancer is one of the leading cancer-related causes of death in Japan. Nexavar as the first and only approved systemic treatment for HCC has been a major advance in this field, but effective second-line treatment options are urgently needed for patients”.
Regorafenib has also been submitted to the regulatory authorities in the US and EU for the treatment of second-line HCC, said Bayer in its press release.
