Avastin is approved in Europe in combination with fluoropyrimidine-based chemotherapy for the treatment of adult patients with metastatic carcinoma of the colon or rectum. The European product information has been updated based on the positive results of the Phase III ML18147 study with an implementation date of December 12, 2012, allowing people with mCRC who received Avastin plus chemotherapy as a first-line treatment to continue to receive Avastin plus chemotherapy after their cancer worsens as part of their second-line treatment.
About the ML18147 Study
ML18147 was a randomized, open-label, Phase III multicenter, multinational trial evaluating the efficacy and safety profile of Avastin plus standard second-line chemotherapy in 820 patients with mCRC whose disease had progressed following Avastin plus standard first-line chemotherapy (irinotecan or oxaliplatin-based). Patients were randomized at progression to one of two treatment arms:
- Arm A: Chemotherapy* plus Avastin (equivalent of 2.5 mg/kg i.v. per week)
- Arm B: Chemotherapy* alone
*Depending on the first-line chemotherapy backbone (fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based), the chemotherapy backbone was switched in the second-line setting.
The primary endpoint of the study was overall survival measured from the time patients were randomized to the second-line treatment. The secondary efficacy endpoints of the study included PFS, overall response rate and safety profile.
About Colorectal Cancer
According to the American Cancer Society, colorectal cancer is the third most commonly diagnosed cancer in both men and women in the United States and the third leading cause of cancer deaths. In 2012, more than 143,000 people were diagnosed and nearly 52,000 individuals were projected to die from the disease in the United States. If colorectal cancer spreads (metastasizes) to distant organs, such as the lungs or the liver, five-year survival declines to 12 percent.
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Avastin is a prescription-only medicine that is a solution for intravenous infusion. It 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 tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize).