Bayer AG's (BYR.L,BAYRY.PK,BAYZF.PK) Bayer HealthCare announced that the Ministry of Health, Labor and Welfare or MHLW in Japan has approved Stivarga (regorafenib) tablets for the treatment of patients with unresectable, advanced/recurrent colorectal cancer or CRC.
The approval of Stivarga by the MHLW is based on results from the pivotal Phase III CORRECT study that demonstrated a statistically significant improvement in overall survival and progression-free survival compared to placebo in patients with metastatic CRC or mCRC whose disease had progressed after approved standard therapies. Stivarga is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression - angiogenesis, oncogenesis and maintenance of the tumor microenvironment.
In Japan, CRC is the third most common cause of cancer death, with over 40,000 people dying every year and almost 100,000 newly diagnosed cases per year.
Regorafenib is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the U.S. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.
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