GENZ results give pause

Genzyme Corp. reported an improved quality of life with its Thyrogen recombinant thyroid stimulating hormone (TSH) as a scanning aid for detecting thyroid cancer. But GENZ is holding off on filing an NDA until meeting with the FDA next month. The glitch is that a few percent of patients did not have their recurrent disease show up on the Thyrogen scans.

"We'll get their guidance on whether we should go forward" with the NDA despite the 6 percent false negative rate, spokesperson Stephen Push said, but "we don't think its an obstacle." ...