30 July 2018 - The U.S. FDA today approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumours of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed, have spread beyond the original tumour site and require systemic anticancer therapy.
This is the first FDA approved drug for this use.
The efficacy of Azedra was shown in a single-arm, open-label, clinical trial in 68 patients that measured the number of patients who experienced a 50% or greater reduction of all antihypertensive medications lasting for at least six months.