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FDA committee refuses to approve use of Fujisawa's Prograft for preventing GHHD in matched, unrelated BMTs.

The Food and Drug Administration's (FDA) Oncologic Drug Advisory Committee voted against approval of Fujisawa Healthcare's tacrolimus (Prograf) for the prevention of graft-versus-host disease (GVHD) in both matched and unrelated bone marrow transplants.

Although tacrolimus is an approved anti-rejection drug for kidney and liver transplant recipients, the FDA committee said that in the case of bone marrow transplantation, the risks seemed to outweigh the benefits.

The majority of the bone marrow transplant patients studied by Fujisawa were undergoing the procedure to eradicate acute or chronic leukemias, lymphomas, and other hematologic cancers. In addition to the immunosuppressants cyclosporine or tacrolimus, all study subjects received the antineoplastic drug methotrexate.

Regardless of whether the marrow came from a sibling or unrelated donor, patients taking tacrolimus experienced higher rates of death and serious adverse events such as renal failure, hyperglycemia, abdominal pain, and abnormal liver function tests, according to FDA reviewer Stephen Hirschfield, MD. He said more patients on tacrolimus than on cyclosporine died, required dialysis, or experienced an adverse event that persisted until death or cancer relapse.

Fujisawa argued that survival might have been worse for tacrolimus patients receiving marrow from sibling donors because a higher percentage of these individuals had advanced cancer. Hirschfield agreed but argued that that could not be the sole explanation for the difference in survival rates.

"I think we need more data to be developed," added panelist Richard Simon, MD of the National Cancer Institute. "If we understood the relationship between the drugs and the deaths, then I think we would feel more comfortable."

Tacrolimus clearly was more effective than cyclosporine in reducing the risk of GVHD, however. Among recipients of unrelated donor marrow, 56% of tacrolimus patients developed GVHD compared with 74% of those given cyclosporine. In the sibling donor study, the cumulative incidence of acute GVHD at 100 days posttransplant was 32% in the tacrolimus group and 44% in the cyclosporine group. Overall, tacrolimus patients also appeared to experience fewer rejection episodes, although statistically, the rates were equivalent.
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Comment:FDA committee refuses to approve use of Fujisawa's Prograft for preventing GHHD in matched, unrelated BMTs.
Publication:Transplant News
Geographic Code:1USA
Date:Jan 31, 1999
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