National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
August 11, 2009 • Volume 6 / Number 16

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FDA Update

Bevacizumab Approved to Treat Metastatic Kidney Cancer

The FDA has approved bevacizumab (Avastin), in combination with interferon alpha, for the treatment of kidney cancer that has spread to other parts of the body. Bevacizumab is now approved for the treatment of five different types of cancer.

This most recent approval is based on the results of the AVOREN trial, an international phase III clinical trial of approximately 650 patients with previously untreated metastatic renal cell carcinoma. Patients in the trial, all of who had undergone a complete or partial removal of the kidney (nephrectomy) and whose cancer was of the clear-cell type, were randomly assigned to receive bevacizumab and interferon alpha or interferon alpha and placebo. There was a nearly twofold improvement in progression-free survival (PFS) in patients in the bevacizumab arm compared with patients in the placebo arm, 10.4 months versus 5.5 months, and a nearly threefold improvement in response rate (measured as tumor shrinkage), 31 percent versus 12 percent. There was a trend toward improved overall survival in the bevacizumab arm, but it was not statistically significant.

The original primary endpoint of the AVOREN trial was overall survival. In a news release, however, Roche, which manufactures bevacizumab, explained that “in prior consultation with the U.S. FDA and European regulatory authorities, the PFS endpoint was accepted as the basis for regulatory approval.”

Warning Labels on TNF Blockers Cite Cancer Risk

New warning labels that highlight the increased risk of lymphomas and other cancers will be required for a class of drugs known as tumor necrosis factor (TNF) blockers, the FDA announced last week. TNF blockers are used to treat a number of immune system diseases, including juvenile rheumatoid arthritis, Crohn disease, and several other inflammatory diseases. The drugs in this class include infliximab (Remicade), etanercept (Enbrel), adalimumab (Humira), certolizumab pegol (Cimzia), and golimumab (Simponi).

The warnings are the result of a safety review initiated earlier this year by the FDA in response to reports to the agency’s adverse event reporting system of malignancies in patients treated with TNF blockers. The analysis, the agency reported, showed an increased risk of cancer “occurring after 30 months of treatment on average.” Approximately half of the cancers identified in the review were lymphomas, including Hodgkin and non-Hodgkin lymphoma. Other malignancies included leukemia, melanoma, and solid organ cancers.

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