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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US Food and Drug Administration (FDA) has approved Torisel (temsirolimus, manufactured by Wyeth) for treating advanced kidney cancer (renal cell carcinoma) after a clinical study with the compound showed improved patient survival. Torisel targets the mammalian form of the “TOR” (”target of rapamycin”) protein that was involved in cell growth and survival. The trial involved 626 patients divided into 3 treatment groups: Torisel alone, Interferon alfa, and Torisel plus interferon. Patients receiving Torisel alone experienced improved overall survival (median O.S. = 10.9 months) versus those who were receiving interferon alfa alone (median O.S. = 7.3 months). Progression free survival (P.F.S.) also improved. On the other hand, the combination treatment did not result in an additive survival. Torisel’s common side effects included rash, fatigue, mouth sores, nausea, edema, and loss of appetite. Source: FDA website. Also check out (the late) Steven Dunn’s comprehensive kidney cancer guide for patients.
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US FDA has approved Tykerb (lapatinib, manufactured by GlaxoSmithKline) in combination therapy with Xeloda (capectabine, manufactured by Roche) for treating HER2 positive, advanced metastatic breast cancer in patients who have previously been treated with other cancer drugs including anthracyclines, taxanes, and trastuzumab (Herceptin, manufactured by Genentech). Tykerb is a dual-receptor tyrosine kinase inhibitor that slows down cancer cell growth by interfering with growth signals. This drug is considered a new molecular entity in cancer treatment. Patients who received the Tykerb-Xeloda combination treatment had a longer time to tumor progression than patients who received only Xeloda. Survival rates data are still not mature (too early to tell). Common side effects included diarrhea, nausea, vomiting, rash, and hand-foot syndrome. Source: FDA website.
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NICE has decided that Tarceva (erlotinib, manufactured by Genentech in the US and distributed by Roche outside of US) costs too much compared with the benefit that NICE has assessed to be limited. This will add flames to the controversy that began with access to another cancer drug, Herceptin (same manufacturers as for erlotinib), for treating breast cancer in the UK. NICE compared the effectiveness of Tarceva with Taxotere (docetaxel, manufactured by sanofi-aventis) and concluded that the data did not show Tarceva presented significant benefits to warrant the higher cost associated with therapy. This does not mean the book is shut to Tarceva, as NICE plans to review Tarceva again in February 2008. Source: Reuters UK. You may also check NICE’s consultation docket for erlotinib here.
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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.