FDA throws wrench into Erbitux plans

Cancer-fighting star Erbitux saw its near-term prospects dim yesterday when FDA asked for more data to support the treatment's use against head and neck cancers. This, after Bristol-Myers Squibb and Eli Lilly pulled their app for expanding Erbitux use to a particular type of lung cancer--when the FDA asked for the same sort of data.

At issue: Some of the clinical trials submitted to support the head-and-neck indication were conducted outside the U.S. and used a different formulation of Erbitux made by Merck KGaA, which sells the treatment in Europe. FDA wants data to show that the U.S.-made formulation will work the same way.

The companies are playing it cool, saying that the agency's questions shouldn't interfere with broadening Erbitux use in the long run. "These questions we've been asked about by the FDA are very specific," Bristol spokesman Brian Henry told the Health Blog. The requests also don't question the efficacy or safety for current Erbitux patients at all, he said.

What's next? The companies are combing their existing data and designing an animal study to prove that the other Erbitux formulation is indeed metabolized the same way. And is Lilly--which bought Erbitux originator ImClone last year--gnashing its teeth in frustration? Not so, the company says. It's focused on the long term.

- see the news from the Indianapolis Star
- read the Health Blog article

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