29 December 2017 - Progenics Pharmaceuticals announced today that the U.S. FDA has accepted for review the new drug application for Azedra in patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumours. 

The FDA granted Progenics’ request for priority review and has set an action date of 30 April 2018 under the Prescription Drug User Fee Act.

The NDA is supported by data from a pivotal phase 2b open-label, multi-centre trial that was conducted under a special protocol assessment with the FDA. The trial met the primary endpoint evaluating the proportion of pheochromocytoma and paraganglioma patients who achieved a 50% or greater reduction of all antihypertensive medication for at least six months, and showed favourable results from a key secondary endpoint evaluating the proportion of patients with overall tumour response as measured by Response Evaluation Criteria In Solid Tumours (RECIST).

Read Progenics Pharmaceuticals press release