FDA panel wants new trial for Genzyme med

More bad news for Genzyme: Its leukemia drug Clolar probably won't get a new indication for adults anytime soon. An FDA advisory panel was less than impressed with the company's data supporting expanded use, and the committee voted 9-3 to urge the agency to require a new, randomized trial.

You see, the data Genzyme submitted with its app didn't compare Clolar with another treatment. "In the absence of a randomized trial, we don't have an evidence-based justification that alternative standard therapy wouldn't be better," said panel member Thomas Fleming, a statistician at the University of Washington in Seattle (as quoted by Reuters).

The company is conducting a study comparing Clolar to an older chemo drug, but those results aren't expected till 2011. And the trial is focused on adults 55 and older, rather than a broader age group. Genzyme said it's too soon to say whether it would launch another comparison study; obviously, the FDA itself has to rule, but it usually goes along with advisory panel recommendations.

As you know, this is just the latest in a series of blows for Genzyme, which has been fighting to get a Boston-area plant back on line after it was contaminated by a virus. The plant produces Genzyme's biggest drugs, and delays in resuming full-on production are making analysts nervous. By contrast, the Clolar setback isn't enormous. An analyst called it "an incremental negative." But it's a negative Genzyme didn't need.

- read the Reuters piece
- see the coverage from the Associated Press

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