Bayer HealthCare announced that a reformulation of the liquid Leukine (sargramostim) 500 mcg vial has been approved by the United States Food and Drug Administration (FDA) and is now available for patients and physicians in the US. The new formulation does not contain EDTA (edetate disodium), which was used in the product's liquid 500 mcg vial manufactured from January 2006 to January 2008.
In January 2008, Bayer withdrew the previously marketed liquid Leukine 500 mcg vial from the US market, because of an increase in spontaneous reporting of certain labelled adverse events, including syncope (fainting). The timing of increased reporting of these adverse events coincided with the change in the formulation of liquid Leukine to include EDTA in 2006.
"We are pleased to bring back to US oncologists and haematologists an EDTA-free formulation of liquid Leukine for the care of their patients," said Dr. Gunnar Riemann, member of the Executive Committee of Bayer HealthCare. "At Bayer, providing effective and safe medicines for patients is our highest priority." Leukine has been used to treat nearly 350,000 cancer patients in the US since 1991. New data will be reported at the upcoming American Society for Clinical Oncology (ASCO) conference regarding the clinical impact of Leukine in cancer care.
Among its indications, Leukine is the only myeloid growth factor approved to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in older adult patients with acute myelogenous leukaemia (AML) and to prolong survival of patients who have undergone allogeneic or autologous bone marrow transplantation (BMT) and are experiencing graft failure or engraftment delay, as compared to historical experience. With the approval and relaunch of liquid Leukine in a non-EDTA formulation, Bayer is closing a special access program that reserved priority access to lyophilized Leukine 250 mcg vials, which does not contain EDTA, for patients with the greatest medical need. Sufficient supply of the new, 'non-EDTA' liquid formulation and lyophilized Leukine is now available to meet cancer care market demand.
Leukine (sargramostim) is a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. Leukine was approved in the United States in 1991, and is marketed by Bayer HealthCare Pharmaceuticals. Leukine is the only growth factor approved in the US for use following induction chemotherapy in older adults with acute myelogenous leukaemia (AML) to shorten the time to neutrophil recovery and reduce the incidence of severe and life-threatening infections and infections resulting in death. Leukine also has been approved in the US for use in four additional indications: myeloid reconstitution following allogeneic and autologous bone marrow transplantation (BMT), peripheral blood stem cell (PBSC) mobilization and subsequent myeloid reconstitution in patients undergoing PBSC transplantation, and bone marrow transplantation failure or engraftment delay.