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FDA Approves Bevacizumab Plus Interferon Alfa for Metastatic Renal Cell Carcinoma NEW YORK -- August 3, 2009 -- The US Food and Drug Administration (FDA) has approved bevacizumab plus interferon alfa for metastatic renal cell carcinoma. This FDA approval was based on data from a randomised, double-blind, placebo-controlled phase 3 study (AVOREN) of 649 patients with previously untreated metastatic renal cell carcinoma. The study showed that patients who received bevacizumab plus interferon alfa had a 67% increase in progression-free survival (PFS) compared with patients receiving interferon alfa plus placebo. Median PFS was 10.2 months for patients who received bevacizumab plus interferon alfa compared with 5.4 months for patients who received interferon alfa alone, corresponding to an 89% improvement in median PFS. In the study, tumour size decreased in 30% of patients in the combination therapy group, compared with 12% of patients in the monotherapy group. There was no improvement in overall survival based on the final analysis after 444 deaths, with a median overall survival of 23 months in the bevacizumab plus interferon alfa arm and 21 months in the interferon alfa plus placebo arm. Adverse events in the study were consistent with those previously reported for bevacizumab or interferon alfa. SOURCE: Roche E-mail this page to a friend or colleague! To print, use this version