FDA Grants Orphan Designation to Iomab-B for Older Patients With AML

The U.S. FDA granted orphan drug designation to Iomab-B for the treatment of relapsed/refractory acute myeloid leukemia (AML) prior to hematopoietic cell transplantation in older patients. Iomab-B is a radioimmunoconjugate composed of BC8 (a novel urine monoclonal antibody) and iodine-131 radioisotope. A multi-center, phase III trial will begin soon to evaluate Iomab-B in patients age ≥55 years with relapsed/refractory AML.

Source: U.S. FDA press release, March 30, 2016.