Nexavar (sorafenib, manufactured by Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals) has been approved by the US FDA to treat patients with inoperable hepatocellular carcinoma. Nexavar is currently already approved for treating advanced renal cell carcinoma (RCC), a kidney cancer. Approval was based on results from an international clinical trial containing 600 patients where patients received either Nexavar or placebo. Nexavar treatment prolonged patient survival to 10.7 months versus placebo of 7.9 months and also delayed tumor progression. Nexavar is a small molecule kinase inhibitor drug. Common side effects included fatigue, weight loss, rash or superficial skin shedding, hand or foot skin reaction, hair loss, diarrhea, anorexia, nausea, abdominal pain, elevated serum lipase, and hypophosphatemia. Rare side effects included inadequate blood supply to the heart or heart attack, and incidence of new high blood pressure. Source: US FDA.
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Nexavar (sorafenib, manufactured by Bayer/Onyx) is currently approved for treating kidney cancer, or advanced renal cell carcinoma in both the United States and in Europe. This drug has been in a Phase III clinical study for advanced liver cancer, and now its manufacturers are planning to file the drug for market approval for the treatment of advanced liver cancer based on its clinical study results. The results showed the drug to significantly prolong patient life.
The patients who are taking Nexavar in the clinical trials will continue to gain access to the drug for their liver cancer treatment. However, this drug is currently not yet approved in the US or EU for the treatment of liver cancer and thus would be prescribed off-label for patients with liver cancer. Nexavar works by blocking blood vessel formation to tumor cells (how tumor cells get fed) and stopping tumor cell growth. Side effects from Nexavar may include birth defects, skin reactions (hand foot syndrome), hypertension, heart problems, and bleeding problems. Visit the official patient information on Nexavar website for more. Source: Bayer and Onyx.