Colorectal cancer is the second leading cause of malignancy-related death in the U.S. It accounts for more than 10% to 15% of all cancer deaths. Every year about 150,000 new cases in the U.S. and about one million cases worldwide are diagnosed.
After a 46-day priority review, the Food and Drug Administration (FDA) approved oxaliplatin (Eloxatin, Sanofi-Synthelabo) as an injection to treat patients with col-orectal cancer that has recurred or progressed following six months of completion of first-line therapy with bolus infusional 5-fluorouracil (5-FU) and leu-covorin (LV) plus irinotecan (Camptosar, Pharmacia). Oxaliplatin will be administered in combination with 5-FU/LV. Approval was based on response rate and interim analysis showing improved time to radiographic progression.
At this time, no results have demonstrated a clinical benefit, such as improvement of disease-related symptoms or increased survival.