Release date: 2017-03-27 Today (March 24), Bayer announced the oral multi-kinase inhibitor regorafenib (trade name: Baiwango) metastatic colorectal cancer and gastrointestinal stromal tumor two indications at the same time through the State Food and Drug Administration Approved by the General Directorate (CFDA) for the treatment of previous fluorouracil, oxaliplatin and irinotecan-based chemotherapy, as well as previous or unsuitable anti-VEGF therapy, anti-EGFR therapy (RAS wild type) Patients with metastatic colorectal cancer (mCRC) who have previously received locally advanced, unresectable or metastatic gastrointestinal stromal tumors (GIST) treated with imatinib mesylate and sunitinib malate patient. As a single-agent oral targeted preparation, regofenib can greatly improve the patient's quality of life, while greatly improving the convenience and compliance of patients taking drugs. This approval has brought new hope to Chinese patients. Colorectal cancer is one of the most common malignant tumors of the digestive tract, and its incidence rate ranks third in malignant tumors. In 2015, China's cancer statistics showed that the incidence and mortality of colorectal cancer in China were among the top five in all malignant tumors, including 37.6/100,000 new cases and 19.1/100,000 deaths. However, early colorectal cancer is not obvious, and most patients are diagnosed at an advanced stage. Professor Li Jin from Shanghai Oriental Hospital affiliated to Tongji University said, “The 5-year survival rate of these patients is only 7%, while the early 5-year survival rate of patients is as high as 92%. Although advanced treatment methods have improved, The medical needs of other treatment options remain high, especially in patients with refractory metastatic colorectal cancer. Rigofenib is the first and only one that has been proven in two previous Phase III clinical trials. Multi-kinase inhibitors that extend overall survival in patients with metastatic colorectal cancer." Gastrointestinal stromal tumors (GIST) are a type of cancer that originates from the mesenchymal tissue of the digestive tract. In recent years, its prevalence has increased. Professor Xu Jianming from Beijing Sanqi Seven Hospital said, “GIST is not sensitive to traditional radiotherapy and chemotherapy. With the emergence of new molecular targeted drugs, the treatment of GIST has made great progress. However, it has accepted the existing approved treatment. Patients with GIST who still have disease progression are still lacking in other effective treatments. The GRID study demonstrates that regorafenib is used in GIST patients who develop disease after treatment with imatinib mesylate and sunitinib malate. Compared with placebo, there was a significant improvement in progression-free survival (PFS)." Rigofenib is an oral multi-kinase inhibitor that targets tumor growth, tumor angiogenesis, and maintenance of the tumor microenvironment. Previously, regofini has been approved for the treatment of metastatic colorectal cancer in more than 90 countries around the world, and more than 70 countries have been approved for the treatment of metastatic gastrointestinal stromal tumors (GIST), including the United States, EU and Japan. Source: Sina Pharmaceutical News Removable Oxygen Cylinder Filling System
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Bayer Rigiginib metastatic colorectal cancer and gastrointestinal stromal tumor dual indications approved domestically