Key clinical point: The FDA has approved iobenguane I 131 injection (Azedra) for intravenous use for the treatment of adults and adolescents aged 12 years and older with rare adrenal tumors (pheochromocytoma or paraganglioma) that are unresectable, have metastasized, and require systemic therapy.
Major finding: The primary endpoint was the number of patients with a 50% or greater reduction of antihypertensive medications lasting at least 6 months; the secondary endpoint was overall tumor response according to traditional imaging criteria. Among 68 patients, the primary endpoint was met by 17, and the secondary endpoint was achieved in 15.
Study details: Approval is based on a single-arm, open-label clinical trial that included 68 patients.
Disclosures: The FDA granted the approval of Azedra to Progenics Pharmaceuticals.
FDA approves iobenguane I 131 injection (Azedra) for IV use for pheochromocytoma or paraganglioma.