Bayer's regorafenib gets priority review for CRC in Japan

Germany’s Bayer (BAYN: DE) say that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted priority review to subsidiary Bayer Yakuhin’s New Drug Application for regorafenib filed at the end of July for the treatment of patients with unresectable, advanced/recurrent colorectal cancer (CRC). The MHLW grants priority review to medicines on the basis of their clinical usefulness and severity of the disease.

“The number of patients suffering from colorectal cancer continues to increase in Japan and for patients with advanced disease, there are limited options. The improved overall survival seen in the CORRECT trial is encouraging and has the potential to provide Japanese physicians with a new option to offer these patients,” said Kemal Malik, a member of the Bayer HealthCare executive committee and head of global development.

In Japan, CRC is the third most common cause of cancer death, with over 40,000 people dying from the disease every year and almost 100,000 people are newly diagnosed per year with the condition. Research also shows that the incidence of CRC has risen dramatically in Japan in the last 20 years.