FDA Approves Eloxatin for Advanced Colorectal Cancer

The U.S. Food and Drug Administration, after a review of only seven weeks, has approved the chemotherapy drug Eloxatin (oxaliplatin) for use by advanced colorectal cancer patients with no other treatment options.

Dr. Richard Pazdur said that the FDA acted in record time because there were no treatment options for colorectal cancer patients once two existing chemotherapy drugs -- 5-FU and irinotecan -- no longer worked.

Eloxatin was approved for use in combination with 5-FU in patients who failed to respond to the combination of 5-FU and irinotecan.

The combination of Eloxatin and 5-FU in a clincal trial shrank tumors by at least 30 percent in 9 percent of patients. The combination of Eloxatin and 5-FU also kept cancer from starting to grow again for 4.6 months, or 2 months longer than for 5-FU alone.

"There really is no treatment option, and these people are desperately seeking treatment for this disease," Pazdur said. Eloxatin already is in wide use in Europe, and Sanofi-Synthelabo said it expects the drug to be on the market in the United States within a month.

Eloxatin failed to get FDA approval. two years ago as an initial treatment for colorectal cancer. Pazdur said the FDA would soon evaluate a study indicating that Eloxatin could prolong survival when given at earlier disease stages.

Other Sources: FDA