Sanofi-Synthélabo announced that Eloxatin (oxaliplatin for injection) in combination with 5FU/LV has been approved by the US Food and Drug Administration (FDA) for the first-line treatment of advanced colorectal cancer. Eloxatin was already approved in August 2002 for second-line treatment of patients with metastatic carcinoma of the colon/rectum in US.
This new approval recommends now the use of Eloxatin, in combination with infusional 5FU/LV, for the treatment of advanced carcinoma of colon or rectum.
The supplemental New Drug Application (sNDA) for Eloxatin in this indication had been submitted on July 11, 2003 in the United States and was granted a six-month priority review in September 2003.
Clinical data show that patients with advanced colorectal cancer treated with Eloxatin given in combination with 5-FU/LV as first-line chemotherapy had a statistically significant improvement of nearly five months in median survival time compared to patients treated with a standard treatment of irinotecan in combination with 5-FU/LV.
"The finding that the oxaliplatin-based regimen demonstrated a longer survival time for patients is a major step forward." said Richard Goldberg, MD, Professor and Division Chief at University of North Carolina (Chapel Hill School of Medicine). "This is the greatest increase in survival time we have seen in a chemotherapy regimen used in advanced colorectal cancer and positions the oxaliplatin-based regimen as an emerging standard of care for patients with colorectal cancer."