FDA Approves Treatment for Use in Acute Radiation Syndrome

Leukine’s approval adds to the United States’ available treatments for radiation exposure associated with treatment for cancer.

The FDA has approved the use of sargramostim (Leukine) to increase survival in adult and pediatric patients acutely exposed to myelosuppressive doses of radiation, known as hematopoietic syndrome of acute radiation syndrome, according to a press release.

Sargramostim is the third FDA-approved treatment that is indicated to increase survival in patients exposed to myelosuppressive doses of radiation. Myelosuppression occurs when radiation damages the bone marrow and blocks the production of blood cells.

This approval is based on efficacy studies in animals. Sargramostim 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 under conditions of minimal supportive care.

Sargramostim 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. It was subsequently approved for several additional oncology-related indications.

Sargramostim works by facilitating the recovery of bone marrow cells that develop into white blood cells that help fight off infections. The most common adverse effects associated with use include fever, injection site reactions, and shortness of breath.