FDA approves first treatment for rare adrenal tumors

The US Food and Drug Administration has approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed (unresectable), have spread beyond the original tumor site and require systemic anticancer therapy.

This is the first FDA-approved drug for this ultra rare disease use, which was granted to US drugmaker Progenics Pharmaceuticals (Nasdaq: PGNX), which gained rights to Azedra along with its acquisition of Molecular Insights in January 2013.

Progenics’ shares rose 8.49% to $8.31 by close of trading on Monday, having risen as much as 12%.