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FDA Grants Priority Review to Novel Iobenguane I-131 Agent for Rare Neuroendocrine Tumors

Silas Inman @silasinman
Published: Friday, Dec 29, 2017

Mark R. Baker

Mark R. Baker
The FDA has granted a priority review designation to a novel version of the radiopharmaceutical iobenguane I-131 (Azedra) for patients with malignant or recurrent pheochromocytoma or paraganglioma (PPGL), according to a statement from Progenics Pharmaceuticals, the company developing the novel iodine-131 metaiodobenzylguanidine (MIBG).

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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