FDA to Provide Accelerated Review for Erbitux

The U.S. Food and Drug Administration notified ImClone Systems it has approved an accelerated review for Erbitux, a promising treatment for advanced colorectal cancer.

ImClone and its U.S. marketing partner, Bristol-Myers Squibb, said the application will be reviewed for accelerated approval, as requested, and has been granted priority review status by the FDA.

The review, which could provide closure for a drug that has generated controversy over both its effectiveness and its bit part in a famous insider-trading scandal involving Martha Stewart, should be completed by Feb. 13, 2004.

The refiling comes nearly two years after the FDA rejected the original application for Erbitux, citing problems with the data. This past May, new data pointing to the effectiveness of Erbitux was provided by ImClone's partner, Merck KGaA, from a European clinical trial.

Other sources: Bristol Myers Squibb, FDA