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New therapy available for renal cell carcinoma and first maintenance therapy is approved for lung cancer.
The Food and Drug Administration approved Avastin (bevacizumab) in combination with interferon for metastatic renal cell carcinoma on July 31, adding to the arsenal of new drugs approved within the past few years for the relatively incurable cancer.
Although there are approved drugs for the treatment of advanced nonsquamous cell non-small cell lung cancer (NSCLC), the approval of Alimta (pemetrexed) in early July marks the first drug available for maintenance therapy of advanced or metastatic disease.
The approval is based on a study presented at this year’s American Society of Clinical Oncology meeting that studied whether patients receiving Alimta after initial chemotherapy, but before disease progression, would benefit. The international phase III trial looked at more than 600 patients who successfully finished four cycles of platinum-based chemotherapy and were randomized to receive either Alimta or placebo. Alimta given every three weeks extended overall survival in patients with nonsquamous cell NSCLC by a median of five months when compared with placebo. However, patients with squamous cell NSCLC did not benefit from the drug, which means tumor histology (how the cells look under the microscope) can now be used to determine NSCLC treatment, a relatively new concept for treating the disease.
Alimta, first approved in 2004 for mesothelioma, is also approved as a first-line therapy for advanced NSCLC and for locally advanced or metastatic NSCLC after prior chemotherapy. Side effects of Alimta include fatigue, nausea, neuropathy, and rash. The drug is typically given with vitamin B12 to lessen side effects. For more information on Alimta, visit www.alimta.com (site is owned by Eli Lilly, the maker of Alimta).
The approval came after results of the phase III AVOREN (Avastin in Renal) study showed nearly a five-month improvement in progression-free survival in patients taking the combination, compared with patients receiving interferon alone (10.2 months versus 5.4 months). Tumor size also decreased in 30 percent of patients taking Avastin, compared with 12 percent on interferon alone; however, no statistically significant improvement in overall survival was seen between the two groups (23 months in the Avastin arm versus 21 months in the interferon-only arm).
Avastin, a targeted drug that blocks the formation of new blood vessels to tumors, is also approved for advanced colorectal, lung, and breast cancers as well as certain brain cancers. Side effects of Avastin can include headache, constipation, and high blood pressure. Avastin also carries rare risks of perforations in the gastrointestinal tract, severe bleeding, and wound healing problems.
For more on kidney cancer, read “Reining in Renal Cancer” from the Summer 2009 issue at www.curetoday.com/reining_in_renal_cancer. For more information on Avastin, visit www.avastin.com (site is owned by Genentech, the maker of Avastin).