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Safety Data Leads to Negative ODAC Vote on Prograf

Safety Data Leads to Negative ODAC Vote on Prograf

GAITHERSBURG, Md—ODAC has declined to recommend that the FDA approve Prograf (tacrolimus, Fujisawa Healthcare) for the prophylaxis of graft-versus-host disease (GVHD) in patients receiving allogeneic bone marrow transplants (BMT).

Fujisawa presented data from two phase III randomized studies involving 509 patients who received either sibling-matched BMTs or transplants from unrelated donors: 255 received Prograf and 254 cyclosporine (Sandimmune). All patients received methotrexate.

The primary endpoint was reduction in acute moderate-to-severe GVHD at 100 days after transplant. The incidence of grade 2-4 GVHD (26% vs 41% and 51% vs 70%) favored Prograf in both studies. In the matched-sibling study, there were more advanced disease patients in the Prograf group, which accounted for a greater incidence of deaths at 6 months (42% vs 32%), the company said. In the unrelated donor study, there was no difference in the incidence of deaths between Prograf and cyclosporine (34% and 38%, respectively).

FDA reviewer Steven Hirschfeld, MD, noted that more Prograf patients went on to dialysis and more suffered a relapse than did patients on cyclosporine. “If we understood the relationship between the drugs and the deaths, I think we would feel more comfortable about making a recommendation,” said Richard M. Simon, DSc, of the NCI.

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