A speedy approval
The FDA's quick OK of a new cancer drug signals a turnaround
Mark Hall was a colon cancer patient whose future looked bleak. After failing to respond to three different types of chemotherapy, he finally turned to an experimental drug. "It turned out to be the silver bullet for me," the 44-year-old from Mercer Island, Wash., says. "I don't think I'd be here if it wasn't for oxaliplatin."
Last week the Food and Drug Administration approved the drug, known commercially as Eloxatin, in record time. "There is really nothing for these patients--we felt a need to get this out," says Richard Pazdur, head of the FDA's cancer drugs review division.
The approval of Eloxatin stands in contrast to the FDA's bungled handling of Erbitux, a promising colorectal cancer treatment from a company called ImClone ["The Drug That Could Have Been," U.S. News, August 19]. Last December, after the FDA turned away Erbitux's application, ImClone's stock nose-dived and its former CEO, Sam Waksal, now faces insider trading charges. But Eloxatin's approval took only seven weeks--the fastest ever for a cancer drug. The move could help to quell some of the criticism lodged against the agency for denying Erbitux to the same patients.
All this could be either good news or bad news for Erbitux. After its application was first rejected by the FDA in 2000, Eloxatin's maker, Sanofi-Synthelabo, conducted very good clinical trials, which could serve as a model for a second try by ImClone. However, with Eloxatin now approved, there is less urgency for the FDA to approve another late-stage colorectal cancer treatment.
This story appears in the August 26, 2002 print edition of U.S. News & World Report.
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