Currently, Azedra is being evaluated in a pivotal Phase IIb trial, which is being conducted under a Special Protocol Assessment Agreement (SPA), and has received orphan drug and fast track designations from the FDA.
Progenics CEO Mark Baker said: "This Breakthrough Therapy designation for Azedra reflects the urgent need for new options for patients suffering from pheochromocytoma and paraganglioma.
"Azedra has the potential to be the first approved therapy for patients with these rare and devastating tumors, and this designation will allow for a close collaboration between Progenics and the FDA as we complete our ongoing pivotal Phase IIb trial and, assuming a positive trial outcome, advance Azedra through the regulatory review process."
Apart from potentially treating pheochromocytoma and paraganglioma, Azedra may also have utility in treating neuroblastoma and other neuroendocrine tumors.
The company has completed clinical trials for Azedra and regulatory approvals for the drug remain subject to the successful completion of all required studies.