- USPLabs agrees to recall and destroy dietary supplement following FDA actions
- 21 health industry groups address FDA on proposed changes to generic drug label rules
- FDA advisory panel to consider OTC status of NSAIDs
- Ensuring access to chronic pain medications
- GPhA: FDA’s proposed rule on prescription drug labeling adds $4 billion to healthcare costs
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating colorectal cancer that has spread to other parts of the body, the agency said Friday.
The FDA announced the approval of Sanofi's Zaltrap (ziv-aflibercept) for adults with metatstatic colorectal cancer, in combination with a chemotherapy regimen comprising folinic acid, fluorouracil and irinotecan, commonly known as FOLFIRI. According to the National Institutes of Health, 143,460 people in the United States will be diagnosed with colorectal cancer, and 51,690 will die from it, in 2012.
"This approval demonstrates the benefits of adding a biological agent, Zaltrap, to a commonly used chemotherapy drug regimen, FOLFIRI," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "An improvement in median survival time was noted with the addition of Zaltrap to FOLFIRI, accompanied by an improvement in response rate and a delay in tumor progression and growth."