FDA APPROVES PROKINE FOR TREATMENT OF BONE MARROW TRANSPLANT ENGRAFTMENT FAILURE
FDA APPROVES PROKINE FOR TREATMENT OF BONE MARROW
TRANSPLANT ENGRAFTMENT FAILURE
SOMERVILLE, N.J., Jan. 3 /PRNewswire/ -- Sargramostim, a yeast- derived granulocyte-macrophage colony stimulating factor, improves survival of cancer patients in whom myeloid engraftment is delayed or is lost after bone marrow transplantation.
Based on study data submitted to the U.S. Food and Drug Administration, Sargramostim will be permitted to be marketed for myeloid engraftment delay or failure. Sargramostim is manufactured by Immunex Corporation and distributed under the trade name Leukine. It is also distributed by Hoechst-Roussel Pharmaceuticals Inc. under the trade name Prokine.
Engraftment delay or failure is an uncommon but serious, and often lethal, complication of bone marrow transplantation. It is estimated that less than half of patients experiencing this complication survive the first 100 days following bone marrow transplantation failure.
"In bone marrow transplantation, 100 days is one benchmark for measuring survival benefit," said Dagmar H. Oette, M.D., director of Oncology/Biologics at Hoechst-Roussel. "According to the study results, more patients were alive at this point if they received Sargramostim."
A total of 140 eligible patients from 35 institutions received Sargramostim and were evaluated in comparison to 103 historical control patients from a single institution. Patients in both groups had undergone either allogeneic or autologous bone marrow transplantation for lymphoid or myeloid leukemia, non-Hodgkin's lymphoma, Hodgkin's disease, aplastic anemia, myelodysplasia or solid tumors. Patients were considered to have delayed or failed myeloid engraftment if the increase in neutrophils did not reach an adequate level (defined as at least 100 cells/mm3), or if engraftment occurred and the graft was subsequently lost (defined as cell count dropping below 500 cells/mm3).
Compared to those of historical controls, 100-day and median survivals were approximately two-fold greater for patients receiving Sargramostim.
Sargramostim stimulates production and differentiation of several types of blood cells, including those important for fighting certain infections. Bone marrow transplantation enables the administration of chemotherapy and/or radiation doses large enough to produce remission of certain cancers. Transplantation necessarily accompanies the treatment because large doses of therapy also destroy the patient's bone marrow. Thus, the bone marrow transplant "rescues" the patient from the treatment.
Sargramostim was licensed in March, 1991, for acceleration of myeloid recovery in patients with non-Hodgkin's lymphoma, Hodgkin's disease and acute lymphoblastic leukemia undergoing autologous bone marrow transplantation.
Hoechst-Roussel Pharmaceuticals Inc. is part of the Life Sciences Group of Hoechst Celanese Corporation. Hoechst Celanese is a wholly owned subsidiary of Hoechst AG of Germany, with leading positions in chemicals, fibers, advanced materials and technologies, and life sciences.
/CONTACT: Kathy Lauri or Michael Durand of Porter/Novelli, 212-315-8000, for Hoechst-Roussel Pharmaceuticals/ CO: Hoechst-Roussel Pharmaceuticals Inc. ST: New Jersey IN: MTC SU: SM -- NY045 -- 6626 01/03/92 17:51 EST