Medication Monitor

Generic Name (Trade Name—Company)
April 2, 2018


(Leukine—Partner Therapeutics)
FDA approves Leukine for acute radiation syndrome

On March 29, 2018, FDA approved the use of sargramostim under the trade name Leukine to increase survival in adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome, or H-ARS). 

The approval adds to the country's available treatments in the event of radiological or nuclear emergency. It is the third FDA-approved medical countermeasure indicated to increase survival in patients exposed to myelosuppressive doses of radiation, following approval of Neupogen in March 2015 and Neulasta in November 2015.

Leukine can help patients with H-ARS by facilitating recovery of bone marrow cells that develop into white blood cells that help fight off infections. It was shown to increase survival when administered up to 48 hours after total body irradiation exposure at doses expected to be fatal to 50% of those exposed subjects under conditions of minimal supportive care. 

Approval was based on efficacy studies in animals (under the Animal Rule), as efficacy studies in humans could not be ethically conducted. 

Leukine was originally approved in 1991 to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections following induction chemotherapy in adult patients aged 55 years and older with acute myeloid leukemia (AML), and subsequently approved for several oncology-related indications.

Its most commonly reported adverse effects are fever, injection site reactions, and shortness of breath.