Sanofi-Synthelabo recently announced that its platinum-based drug oxaliplatin(Drug information on oxaliplatin) (Eloxatin) has been approved by the US Food and Drug Administration (FDA) for use in combination with infusional fluorouracil(Drug information on fluorouracil) (5-FU)/leucovorin in advanced colorectal cancer patients whose disease has recurred or progressed after bolus 5-FU/leucovorin plus irinotecan(Drug information on irinotecan) (CPT-11, Camptosar) therapy. The FDA approval is based on the response rate and improved time to tumor progression observed in an ongoing trial. Data that demonstrate a clinical benefit, such as improvement in disease-related symptoms or an increase in survival are not yet available.
In the pivotal investigation, oxaliplatin in combination with infusional 5-FU/leucovorin demonstrated a statistically significant response rate compared with infusional 5-FU/leucovorin alone. Additionally, interim data from the investigation on the median time to disease progression showed an increase of 2 months with the oxaliplatin combination, compared to infusional 5-FU/leucovorin alone.
"Eloxatin in combination with infusional 5-FU/leucovorin provides an alternative for patients who previously had only limited options," said Mace Rothenberg, md, lead investigator for the trial and Ingram Associate Professor of Cancer Research at the Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, Tennessee. In addition, he noted, "oxaliplatin is being evaluated for its impact on disease-related symptoms including pain, weight loss, fatigue, and its effect on survival."
Dan Haller, md, professor of medicine at the University of Pennsylvania Cancer Center, and who directs other clinical studies with oxaliplatin, said, "Eloxatin in combination with infusional 5-FU/leucovorin adds a new weapon to what has been a very small arsenal of effective treatments for advanced colorectal cancer. In patients whose advanced colorectal cancer has recurred or progressed, meaningful options have been few." He added, "The approval of Eloxatin may change the way we treat our patients."
Clinical Trial Results
The New Drug Application for oxaliplatin was based on the results of a US-Canadian multicenter, randomized, controlled investigation. This study compared the safety and efficacy of oxaliplatin plus infusional 5-FU/leucovorin with that of infusional 5-FU/leucovorin alone and oxaliplatin alone.