FDA grants Actinium’s Iomab-B orphan drug designation

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Iomab-B, a radioimmunotherapeutic developed by Actinium Pharmaceuticals that is designed to aid patients with reverted and stubborn Acute Myeloid Leukemia (AML) so they can receive a Hematopoietic Stem Cell Transplant (HSCT).

The HSCT procedure is more commonly known as Bone Marrow Transplant (BMT).

A Phase 3 clinical trial for Iomab-B is scheduled to begin in the near future. The study will consist of 150 patients in multiple centers who are over the age of 55 and have relapsed or refractory AML.

According to Executive Chairman Sandesh Seth, Actinium is pleased by the FDA’s decision to grant Iomab-B orphan drug designation, especially since the drug is headed for its pivotal Phase 3 trial. Iomab-B would be the first drug approved for patients with relapsed and refractory AML who are older than 55 years of age in decades. Currently, the drug is the only therapy of its kind that has reached clinical trials.

With Iomab-B being granted orphan drug designation, Actinium is entitled to developmental and financial incentives, which includes a seven year market exclusive in the U.S.