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Title: Eloxatin Receives Expanded Indication For Metastatic Colorectal Cancer
URL: http://www.pslgroup.com/dg/799FA.htm
Doctor's Guide
May 6, 1998


PARIS, FRANCE -- May 6, 1998 -- Sanofi announced today that oxaliplatin, marketed in France under the trademark Eloxatin(R), has been approved in France as a first-line treatment for metastatic colorectal cancer in association with fluoropyrimidines and as the sole treatment in patients for whom the administration of fluoropyrimidines is not appropriate.

Colorectal cancer constitutes a major public health problem. In France, it accounts for 15 percent of all cancers, with 33,000 new cases diagnosed each year. One French person in 25 is likely to be affected by colorectal cancer, with a 50 percent survival rate at five years.

Eloxatin is a new cytotoxic agent which has been marketed by Sanofi in France since September 1996 in the treatment of metastatic colorectal cancers after an initial chemotherapy has failed.

The French approval, based on comparative clinical trials carried out on more than 600 metastatic patients not previously treated, demonstrated the efficacy of Eloxatin in association with 5-fluorouracil (5FU) compared with standard chemotherapies; that is once chemotherapy is indicated as a treatment for a patient with metastatic colorectal cancer. In these studies, Eloxatin led to improved tumour control and prolonged remission in comparison with the standard chemotherapy used in the trial.

Adverse events commonly associated with the use of Eloxatin with 5FU included nausea and vomiting, peripheral sensory neuropathy and myelosuppresion.

With the approval of Eloxatin as a first-line treatment of metastatic colorectal cancer in France, Sanofi moves to a new stage in the area of oncology. Eloxatin is currently under investigation in the U.S.

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