Progenics Pharmaceuticals, an oncology company developing medicines and imaging analytical tools for targeting and treating cancer, announced today that the FDA has accepted for review the New Drug Application (NDA) for Azerda in patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors. The FDA granted Progenics’ request for Priority Review and has set an action date of April 30, 2018 under the Prescription Drug User Fee Act (PDUFA).
“With no FDA-approved therapies for these rare tumors, Azerda has the potential to address the high unmet need of patients with malignant pheochromocytoma and paraganglioma,” said Mark Baker, CEO of Progenics. “We are pleased that the FDA has accepted our NDA with Priority Review, and look forward to working with the Agency during the review process. At the same time, we will continue to lay the groundwork for our commercial plan and prepare to launch quickly following a potential approval.”
The NDA is supported by data from a pivotal phase 2b open-label, multi-center trial that was conducted under a Special Protocol Assessment (SPA) with the FDA. The trial met the primary endpoint evaluating the proportion of pheochromocytoma and paraganglioma patients who achieved a 50 percent or greater reduction of all antihypertensive medication for at least six months, and showed favorable results from a key secondary endpoint evaluating the proportion of patients with overall tumor response as measured by Response Evaluation Criteria In Solid Tumors (RECIST). Azerda was also shown to be safe and generally well tolerated.
(Source: Progenics Pharmaceuticals, Inc.)
Filed Under: Drug Discovery