This article is more than 5 years old. Information may no longer be current.
FDA grants breakthrough therapy designation to Azedra for pheochromocytoma, paraganglioma
Click Here to Manage Email Alerts
The FDA granted breakthrough therapy designation to Ultratrace iobenguane I-131 for the treatment of patients with iobenguane-avid metastatic or recurrent pheochromocytoma and paraganglioma, according to a press release from the drug’s manufacturer.
Ultratrace iobenguane I-131 (Azedra, Progenics Pharma), a late-state radiotherapeutic drug candidate, is being evaluated in a phase 2b trial of patients with malignant pheochromocytoma or paraganglioma. Pheochromocytomas — rare tumors usually found within one or both adrenal glands — are referred to as paragangliomas when they arise in other areas of sympathetic nerve cells.
Ultratrace iobenguane I-131 — a very high specific activity form of iobenguane I-131 — is produced using Progenics’ Ultratrace platform, a technology designed to prevent unlabeled iobenguane from being carried through the manufacturing process to the final formulation, according to information listed on Progenics’ website. Ultratrace iobenguane I-131 is designed for use as an imaging agent in order to determine a therapeutic dose that is safe for normal organs, as well as for therapy.
The FDA previously granted orphan drug and fast track designations to Ultratrace iobenguane I-131.
"This breakthrough therapy designation for Azedra reflects the urgent need for new options for patients suffering from pheochromocytoma and paraganglioma," Mark R. Baker, CEO of Progenics Pharma, said in a press release. "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 2b trial and, assuming a positive trial outcome, advance Azedra through the regulatory review process."