Bayer debuts reformulated Leukine in USA

Germany-headquartered Bayer HealthCare says that a reformulation of the liquid Leukine (sargramostim) 500mcg vial has been approved by the US Food and Drug Administration and is now available for patients and physicians in that country.

The new formulation does not contain edetate disodium, which was in the product's liquid 500mcg vial manufactured from January 2006 to January 2008, but was withdrawn in January due to an increase in spontaneous reporting of certain labeled adverse events, including syncope (fainting).

"The reintroduction of liquid sargramostim without EDTA is welcome news to oncologists and hematologists," said Mark Heaney, associate attending physician, Memorial Sloan-Kettering Cancer Center, New York, who has studied the biology of the receptor of this drug for more than a decade. "Sargramostim has an important role in reducing life-threatening infections and early death due to infections among older adults (> 55 years of age) with acute myelogenous leukemia (AML). Further, sargramostim is an important therapy in cancer supportive care and has a proven survival benefit in patients experiencing bone marrow transplant failure or engraftment delay," he added.