Bayer AG’s Bayer Yakuhin Ltd Submits Regorafenib For Treatment Of Gastrointestinal Stromal Tumors In Japan

Bayer AG announced that Bayer Yakuhin Ltd has submitted for marketing authorization the oral multi-kinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) to the Ministry of Health, Labour and Welfare (MHLW) in Japan. This follows the submission of regorafenib to MHLW for the treatment of colorectal cancer (CRC) which received priority review at the end of August 2012. The submission to the MHLW is based on the positive results from the pivotal Phase III GRID (GIST – Regorafenib In Progressive Disease) trial which took place across the globe, including eight sites in Japan.