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US FDA accepts Progenics Pharmaceuticals' tumor therapy for review

The U.S. Food and Drug Administration has accepted for review the new drug application of Progenics Pharmaceuticals Inc.'s Azedra to treat malignant, recurrent or unresectable pheochromocytoma and paraganglioma.

Pheochromocytoma and paraganglioma are rare neuroendocrine tumors that arise from the cells of the autonomic nervous system.

The FDA granted Progenics' request for priority review, with an expected action date of April 30, 2018.

Azedra's application is supported by data from a phase 2b trial, conducted under a special protocol assessment with the FDA, which met the main goal that evaluated the proportion of pheochromocytoma and paraganglioma patients who achieved a 50% or greater reduction of all antihypertensive medication for at least six months.