(Released 29 March 2018) On March 29, 2018, the FDA approved use of Leukine (sargramostim) to increase survival in adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS).
Myelosuppression occurs when radiation damages the bone marrow. Suppression of the bone marrow blocks the production of blood cells. 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.
Leukine 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.
Leukine is the third FDA-approved medical countermeasure (MCM) that is indicated to increase survival in patients exposed to myelosuppressive doses of radiation. It was approved by FDA 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 and was originally indicated to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML), and subsequently approved for several oncology-related indications.
The most commonly reported side effects associated with Leukine injections are fever, injection site reactions, and shortness of breath.
Other products from a similar pharmacological class and approved for the same indication are:
- Neupogen (March 2015)
- Neulasta (November 2015)
For more information about Leukine, visit: Radiological and Nuclear Emergency Preparedness Information from FDA.
Released by the U.S. Food and Drug Administration.