FDA approves Avastin plus interferon-alfa for people with metastatic renal cell carcinoma

Genentech, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Avastin (bevacizumab) plus interferon-alfa for people with metastatic renal cell carcinoma, the most common type of kidney cancer. According to the American Cancer Society, kidney cancer is the eighth most commonly diagnosed cancer in the United States. In 2009, approximately 13,000 Americans will die from the disease.

"During the last five years, Avastin has been approved by the FDA to treat five different types of cancer," said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. "We aim to help more people facing difficult-to-treat cancers and will continue studying Avastin in more than 30 other tumor types."

Avastin is designed to block the vascular endothelial growth factor (VEGF) protein to address a key underlying cause of cancer growth. Avastin works differently than other approved medicines for renal cell carcinoma because it specifically binds to the VEGF protein, which is produced in elevated amounts in most kidney cancers.

"We hope that researchers someday find a cure for kidney cancer," said William P. Bro, chief executive officer of the Kidney Cancer Association. "Until then, each new medicine, like Avastin, offers patients an opportunity to find a treatment best suited for them."

Kidney cancer is the uncontrolled growth of cancerous cells that originate in the kidneys without a known cause. Nine out of ten people with kidney cancer have renal cell carcinoma.

This FDA approval is based on data from a global, randomized, double-blind, placebo-controlled Phase III 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.

The study was originally designed to measure an improvement in overall survival (OS). However, in prior consultation with the FDA and European regulatory authorities, the primary analysis endpoint was revised to assess improvement in PFS.

Secondary analysis endpoints included objective response rate and OS. In this study, tumor size decreased in 30 percent of patients in the Avastin plus interferon-alfa group, compared to 12 percent of patients who received interferon-alfa alone. There was no improvement in OS based on the final analysis after 444 deaths, with a median OS of 23 months in the Avastin plus interferon-alfa arm and 21 months in the interferon-alfa plus placebo arm (hazard ratio=0.86, 95 percent CI=0.72, 1.04).

Adverse events in this study were consistent with those previously reported for Avastin or interferon-alfa. The most common severe (Grade 3 to 5) adverse events that occurred at a rate of at least 2 percent more often in patients who received Avastin plus interferon-alfa versus interferon-alfa plus placebo included fatigue (13 percent vs. 8 percent), weakness (10 percent vs. 7 percent), protein in the urine (7 percent vs. 0 percent), hypertension (6 percent vs. 1 percent) and bleeding (3 percent vs. 0.3 percent).