The FDA has accepted the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.
However, between 15 and 20% of patients are diagnosed after they have already progressed to late-stage metastatic disease ... certain mutations may render advanced PPGL particularly vulnerable ...
The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.
Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed promising response rates in patients with advanced, unresectable, or metastatic pheochromocytoma and ...