August 03, 2009
Avastin approved for metastatic renal cell carcinomaGenentech has received FDA approval for Avastin (bevacizumab) plus interferon-alfa for treatment of metastatic renal cell carcinoma. This approval is based on data from a global, randomized, double-blind, placebo-controlled Phase 3 study (AVOREN) of 649 patients with previously untreated metastatic renal cell carcinoma. The study showed patients who received Avastin plus interferon-alfa had a 67 percent increase in the time patients lived without their disease worsening (progression-free survival or PFS), compared to those who received interferon-alfa alone (hazard ratio=0.60, 95 percent CI=0.49, 0.72). In AVOREN, median PFS was 10.2 months for patients who received Avastin plus interferon-alfa compared to 5.4 months for patients who received interferon-alfa alone, corresponding to an 89 percent improvement in median PFS.
Avastin, an angiogenesis inhibitor, is already indicated for the treatment of: metastatic colorectal carcinoma, in combination with 5-FU-based chemotherapy; first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), in combination with carboplatin and paclitaxel; and metastatic HER2-negative breast cancer in patients who have not received chemotherapy, in combination with paclitaxel; and in the treatment of glioblastoma with progressive disease following prior therapy as a single agent.
For more information call (800) 821-8590 or visit www.avastin.com.