US Food and Drug Administration (FDA) has approved Ixempra (ixabepilone, manufactured by Bristol-Myers Squibb) for combination treatment with capecitabine (brand name Xeloda, manufactured by Roche) and single-agent monotherapy for treating metastatic or locally advanced breast cancer that has not responded to other chemotherapy (doxorubicin, epirubicin, paclitaxel, or docetaxel). Ixempra belongs to a class of chemical called epothilones and work by binding to cancer cell microtubules, which interferes with cell division. Since Ixempra is in a Cremophor vehicle (same used for Taxol), those allergic to Cremophor or related chemicals should not take Ixempra. Side effects include peripheral neuropathy (numbness, tingling or burning in the hands or feet), bone marrow suppression, constipation, nausea, vomiting, muscle paint, joint pain, fatigue and general weakness. Source: US FDA. Visit drug website.
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The US Food and Drug Administration (FDA) has approved Taxotere (docetaxel, manufactured by Sanofi-Aventis) for combination therapy with cisplatin and 5-fluorouracil to treat locally advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) prior to chemoradiotherapy and surgery. All patients involved in the clinical trial had inoperable tumors or potentially operable tumors but unlikely to be cured by surgery alone. Approval was based on results of TAX 324, a Phase 3 randomized open-label international trial involving over 500 patients assigned to either a Taxotere/Platinum/Fluorouracil (TPF) arm or a platinum/fluorouracil arm (PF). Taxotere-added arm showed longer median overall survival (O.S.) rate of 70.6 months versus non-Taxotere arm of 30.1 months. Both arms had similar grade 3/4 toxicities although Taxotere-treated arm had more febrile neutropenia, neutropenic infection, and grade 3/4 neutropenia. Non-taxotere treated arm had more grade 3/4 thrombocytopenia, stomatitis, lethargy, and vomiting. Other grade 3/4 events common to both treatments included nausea, anorexia and constipation. Taxotere is already approved for treating breast cancer, lung cancer, prostate cancer, and gastric (stomach) cancer. Source: sanofi-aventis.
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According to Dr. Stephen Chia from the University of British Columbia in Vancouver, Canada, women diagnosed with advanced breast cancer experience longer survival times than those diagnosed even a decade ago. New chemotherapies and new biological cancer medicines have made this possible. Dr. Chia reported that patients survive on an average of 438 days when diagnosed in 1991-1992, 450 days when diagnosed in 1994-1995, 564 days when diagnosed from 1997-1998, and 667 days when diagnosed from 1999-2001. This population study is the first of its kind to show that women recently diagnosed with metastatic breast cancer are more likely to have improved survival over time because newer agents are available for treatment. Source: Reuters.
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European Commission (EC) has approved the oral 5-FU drug Xeloda (Capecitabine, manufactured by Roche) in combination therapy with a platinum chemo for treatment of advanced stomach cancer. Approval was based on two trials, ML17032 and REAL 2, that showed comparable or better survival rates to standard therapy. Common side effects included diarrhea, abdominal pain, nausea, stomatitis and hand-foot syndrome.
Another Roche drug in the EU, anti-angiogenic biologic Avastin (bevacizumab, manufactured by Genentech and marketed by Roche) has been approved for treating metastatic breast cancer in combination with paclitaxel. Approval was based on the Phase III trial data E2100 which showed twice the survival rate over paclitaxel treatment alone. Common side effects included diarrhea, fatigue, increased chance of infection, loss of appetite, loss of hair, mouth sores, nausea, rash on the hands and feet, tingling or numbness in fingers or toes, and vomiting.
Source: PharmaLive 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.