Commenting on the approval, William M. Burns, CEO of Roche's Pharmaceuticals Division said, "Avastin has now been approved for five different types of cancer in the USA. This underscores our belief in the important clinical benefits that Avastin delivers as we push forward with our ongoing research programs in more than 30 tumour types."
The FDA approval is based on data from the pivotal phase III study (AVOREN) in patients with advanced, previously untreated metastatic renal cell carcinoma. The study showed that patients who received Avastin plus interferon alpha lived nearly twice as long without their disease getting worse compared to those who received interferon alpha alone; 10.2 months versus. 5.4 months respectively.
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."
In Europe, Avastin has been available since the end of 2007 for the first-line treatment of patients with advanced and/or metastatic renal cell cancer in combination with interferon alpha.
Kidney cancer is the uncontrolled growth of cancerous cells that originate in the kidneys with no 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, randomised, 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 alpha had a 67% increase in the time patients lived without their disease worsening (progression-free survival or PFS), compared to those who received interferon alpha alone (hazard ratio=0.60, 95% CI=0.49, 0.72). In AVOREN median PFS was 10.2 months for patients who received Avastin plus interferon alpha compared to 5.4 months for patients who received interferon alpha alone corresponding to an 89% improvement in median PFS.
The study was originally designed to measure an improvement in overall survival (OS). However, in prior consultation with the U.S. FDA and European regulatory authorities, the PFS endpoint was accepted as the basis for regulatory approval.
Secondary analysis endpoints included objective response rate and OS. In this study, tumour size decreased in 30% of patients in the Avastin plus interferon alpha group, compared to 12% of patients who received interferon alpha alone. 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 Avastin plus interferon alpha arm and 21 months in the interferon alpha plus placebo arm (hazard ratio=0.86, 95% CI=0.72 , 1.04).
Adverse events in this study were consistent with those previously reported for Avastin or interferon alpha.
Avastin is an antibody that specifically binds and blocks VEGF (vascular endothelial growth factor). VEGF is the key driver of tumour angiogenesis - an essential process of development and maintenance of blood vessels which is required for a tumour to grow and to spread (metastasize) to other parts of the body. Avastin's precise mode of action helps control tumour growth and metastases with only a limited impact on side effects of chemotherapy.
Avastin has proven survival benefits across multiple tumour types. Avastin is approved in Europe for the treatment of the advanced stages of four common types of cancer: colorectal cancer, breast cancer, non-small cell lung cancer (NSCLC) and kidney cancer. These types of cancer collectively cause nearly 3 million deaths each year. In the US, Avastin was the first anti-angiogenesis therapy approved by the FDA and is now approved for the treatment of five tumour types: colorectal cancer, non-small cell lung cancer, breast cancer, glioblastoma, and renal cell carcinoma.
More than 500,000 patients have been treated with Avastin so far. A comprehensive clinical programme with more than 450 clinical trials is investigating the use of Avastin in various tumour types (including colorectal, breast, lung, brain, gastric, ovarian, prostate cancers and others) and different settings (advanced or early stage disease).
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