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Weekly UpdatesGenentech, Inc., South San Francisco, Calif., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has 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.
Avastin in Metastatic Kidney Cancer
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).
About Avastin
Avastin is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the blood supply to a tumor by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. Avastin does not bind to receptors on normal or cancer cells. The tumor blood supply is thought to be critical to a tumor!s ability to grow and spread in the body (metastasize).
For more information about angiogenesis, visit http://www.gene.com.
Avastin was the first anti-angiogenesis therapy approved by the FDA. In addition to metastatic renal cell carcinoma, Avastin is indicated for the first-or second-line treatment of metastatic colorectal cancer plus intravenous 5-FU based chemotherapy and for the first- line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer plus carboplatin and paclitaxel.
About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a wholly- owned member of the Roche Group, has headquarters in South San Francisco, Calif.
For more information, visit http://www.gene.com or call 650/467-6800.
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