Bayer, the German Pharmaceutics company, has applied this Monday to acquire an authorization to have its drug Regorafenib in the market. After all liver cancer patients successfully finish the clinical trials, Bayer can get the approval of the second-line treatment.
This new drug is complemental for Stivarga, a medicine that treats colorectal cancer (mCRC) and gastrointestinal stromal tumors already. Worldwide almost 800,000 people are diagnosed with Hepatocellular carcinoma per year, and it has been increasing. Just in the United States, the incidence of liver cancer was present in over 39,000 cases, and that number has tripled since 1980s average. Globally, liver related cancer is the second deadliest type of cancer.
“For nearly a decade and counting, Bayer has been committed to meeting the needs of those with liver cancer with our proven first-line systemic therapy in unresectable HCC patient’s therapy, Nexavar,” said Dario Mirski, M.D., Bayer’s senior vice president and head of medical affairs for the Americas. “Clearly, more options are needed for these patients, especially in the second-line setting. The filing of Stivarga in HCC demonstrates our commitment to ongoing research in this difficult-to-treat cancer.”
About Regorafenib and Hepatocellular Carcinoma
Today, Hepatocellular carcinoma (HCC) represents about 75%-80% of liver cancer cases around the world. This type of cancer is the fifth most common among men and ninth among women globally, and the Western Pacific Area is the most affected area, with over 500,000 cases nowadays. Just four years ago, over 746,000 people died because of liver cancer.
The U.S. Food and Drug Administration Office granted Stivarga the “Fast Track” designation. This is a mechanism designed to accelerate the development and expedite the review of drugs in cases related to life-threating diseases. It needs to be considered on this matter that the tolerability and safety that this medicine gives to the consumers use to be highly consistent.
Right now in the US, Stivarga (Regorafenib first line treatment) is indicated for patients with severe and advanced cases of colorectal cancer, which were previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Also, it is recommended to patients with metastatic gastrointestinal stromal tumor (GIST). In order for this medicine to be appropriate, the patient must have been under the treatment of imatinib mesylate and sunitinib malate.
Source: PR Newswire