First treatment approved for ultra-rare tumors
CAMBRIDGE, MA, August 23, 2018 - PROMETRIKA, LLC extends its congratulations to our colleagues at Progenics Pharmaceuticals, Inc., on the recent approval of Azedra® (iobenguane I 131). PROMETRIKA is honored and proud to have supported Progenics through the integrated safety and efficacy analyses and preparation of the NDA submission documents for the approval of Azedra. The new treatment is approved for the treatment of adult and pediatric patients 12 years and older with iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. Azedra is the first treatment approved in the US for these ultra-rare tumors.
The FDA’s announcement of this milestone approval can be found here.