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FDA grants orphan drug designation to Iomab-B for AML in the elderly
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The FDA granted orphan drug designation to Iomab-B for the treatment of elderly patients with relapsed and refractory acute myeloid leukemia.
Iomab-B (Actinium Pharmaceuticals) — a radioimmunoconjugate composed BC8, a novel urine monoclonal antibody, and iodine-131 radioisotope — conditions patients with relapsed and refractory AML for hematopoietic stem cell transplant.
A multicenter phase 3 trial scheduled to begin soon will evaluate the agent in patients aged older than 55 years with relapsed, refractory disease.
“We are pleased to have been granted orphan drug status by the FDA for Iomab-B, particularly ahead of its pivotal phase 3 clinical trial,” Sandesh Seth, executive chairman of Actinium, said in a press release. “There has not been a new drug approved for relapsed and refractory AML patients over the age of 55 in decades and, with Iomab-B being the only therapy of its kind, we are pleased to have achieved this important milestone.”
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.