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FDA Approves Iobenguane I-131 for Rare Neuroendocrine Tumors

Jason M. Broderick @jasoncology
Published: Monday, Jul 30, 2018

The FDA has approved iobenguane I-131 (Azedra) for adult and pediatric patients aged ≥12 years with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic anticancer therapy.

An expanded access program for iobenguane I-131 is currently available for patients with MIBG-avid malignant and/or recurrent PPGL. Outside of providing access to the medication, the program also plans to further assess safety (NCT02961491).
Jimenez C, Chin BB, Noto RB, et al. AZEDRA (iobenguane I 131) in patients with malignant and/or recurrent pheochromocytoma/paraganglioma (PPGL): Final results of a multi-center, open-label, pivotal phase 2b study. Presented at: NANETS 2017 Symposium; October 19-21, 2017, Philadelphia, PA. Abstract C-28.

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