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New Therapy Approved by FDA for Rare Adrenal Gland Tumors
The US Food and Drug Administration has approved a drug for the treatment of certain adults and pediatric patients who have unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL).
Iobenguane I 131 (AZEDRA; Progenics Pharmaceuticals) received approval for use in patients aged 12 years or greater who have iobenguane scan–positive, unresectable, locally advanced or metastatic PPGL and require systemic anticancer therapy. The FDA granted Iobenguane I 131 a priority review and fast track status for this indication, as well as breakthrough therapy and orphan drug designations.
This approval was based on Study IB12B, an open-label, single-arm, multicenter clinical trial comprising 68 evaluable patients aged 12 years or greater with iobenguane scan–positive, unresectable, locally advanced or metastatic PPGL. Of these 68 patients, 17had a ³50% reduction of all antihypertensive medication for at least 6 months, and 15 patients experienced an overall tumor response. Approximately 50% of patients had a duration of overall tumor response of at least 6 months.—Janelle Bradley
