FDA grants priority review to Azedra for rare neuroendocrine tumors
8 days ago - By Healio
The FDA granted priority review to iobenguane I 131 for the treatment of patients with malignant, recurrent or unresectable pheochromocytoma and paraganglioma, according to the agent's manufacturer.
There are no FDA-approved treatments for these rare neuroendocrine tumors.
Iobenguane I 131 is a substrate for norepinephrine reuptake transporter, which is highly expressed in neuroendocrine tumors. The FDA previously granted orphan drug and breakthrough therapy designations to the agent.
The FDA based the priority review designation on results of an
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