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.

The U.S. Food and Drug Administration (FDA) has approved bevacizumab (Avastin™, Genentech) as a first-line treatment for patients with metastatic colorectal cancer. A monoclonal antibody, it is the first FDA-approved product that prevents the formation of new blood vessels, a process known as angiogene-sis. Avastin™ extended patients’ lives by about five months when it was given intravenously as a combination treatment with standard chemotherapy drugs for colon cancer in a regimen consisting of ironotecan, 5-fluorouracil (5-FU), and leucovorin (IFL).

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Oxaliplatin for injection (Eloxatin™, Sanofi-Synthelabo/Debiopharm SA), in combination with 5-fluorouracil/leuco-vorin (5-FU/LV), has been approved by the FDA for the first-line treatment of advanced colorectal cancer. Eloxatin™ was approved in 2002 for the second-line treatment of patients with metastatic carcinoma of the colon or rectum.

In a study sponsored by the National Cancer Institute and coordinated by the North Central Cancer Treatment Group (NCCTG), patients treated first with Eloxatin™, combined with infusional 5-FU/LV (the FOLFOX regimen), experienced an overall median survival time of 19.4 months after starting therapy. Patients taking a standard combination of irinotecan (Camptosar®, Pharmacia & Upjohn) plus 5-FU/LV (the IFL regimen) had a median survival time of 14.6 months; therefore, the median survival advantage for the FOLFOX patients was 4.8 months (a 35% improvement). The FOLFOX group reported less severe, more manageable, and more reversible side effects than the IFL group did.)