Sanofi Seeks to Expand Use of Eloxatin Following FDA Approval

Sanofi-Synthélabo announced it has submitted a supplemental New Drug Application with the U.S. Food and Drug Administration seeking approval to use its chemotherapy drug Eloxatin (oxaliplatin for injection) for treatment of patients following surgery for colon cancer.

The follow-up application came only a week Eloxatin was approved for the first line treatment of advanced colorectal cancer in the United States.

Even after surgery, a significant percentage of patients with colorectal cancer relapse. Sanofi is proposing to use Eloxatin to eliminate any remnants of cancer cells that were not removed by surgery and to minimize the chance of a recurrence.

"The submission for Eloxatin [for this puerpose] will allow to extend patients' benefit to early stages and therefore curable stages of the disease," said Professor Aymery de Gramont, Head of Oncology Division at Saint-Antoine Hospital, Paris.

"The major reduction in disease recurrence obtained with Eloxatin in [this use] will significantly impact the treatment of early stages of the disease, especially the ones with lymph nodes involvement," de Gramont added.

Eloxatin has been approved for second line treatment of colorectal cancer in Europe since 1996 and for first line since 1999. However, the drug was only approved for second line treatment of advanced colorectal cancer in the U.S. in August 2002 and for first line this month.

Other Sources: Sanofi