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Bayer AG's Bayer Yakuhin Ltd. Regorafenib Granted Priority Review in Japan for the Treatment of Patients with Gastrointestinal Stromal Tumors

Tuesday, 26 Feb 2013 03:05am EST 

Bayer AG’s Bayer HealthCare announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review to Bayer Yakuhin, Ltd., Osaka, Japan, for regorafenib in the treatment of patients with unresectable and/or metastatic gastrointestinal stromal tumors (GIST). Regorafenib was submitted for marketing approval in GIST in Japan in December 2012. The MHLW grants priority review to medicines on the basis of their clinical usefulness and severity of the disease. Regorafenib has also been submitted to MHLW for the treatment of colorectal cancer (CRC) and was granted priority review in this indication at the end of August 2012. The submission 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. The GRID study evaluated regorafenib plus best supportive care (BSC), versus placebo plus BSC in patients with metastatic and/or unresectable GIST whose disease had progressed despite prior treatment with imatinib and sunitinib. Regorafenib plus BSC significantly improved progression-free survival (PFS) compared to placebo plus BSC. The overall safety and tolerability profile for regorafenib in the GRID study was consistent with results from previous studies. Results from the study were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012. 

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