FDA Okays Priority Review of Oxaliplatin for Advanced Colorectal Cancer

The U.S. Food and Drug Administration (FDA) has granted a six-month priority review to the investigational chemotherapy drug Eloxatin® (oxaliplatin) for treatment of advanced colorectal cancer, according to the drug's manufacturer Sanofi-Synthelabo.

The supplemental New Drug Application for Eloxatin was submitted following announcement of results of a trial which showed that a treatment regime called FOLFOX4, which adds oxaliplatin to a potent drug cocktail, helps some patients whose advanced colorectal cancer continues to progress after other therapies (see earlier Colorectal Cancer Week story).

Patients receiving the FOLFOX regimen had a statistically significant improvement in terms of response rate, progression free survival , overall survival and safety profile.

The filing in the United States and in Europe for approval of the use of Eloxatin for supplemental treatment of advanced colorectal cancer should occur later this year, a company spokesperson said.

Other sources: Sanofi-Synthelabo