NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced today that updated biochemical tumor marker data from its pivotal Phase 2 trial of AZEDRA® (iobenguane I 131) were presented at the Endocrine Society’s 2021 Annual Meeting, ENDO 2021.
Lantheus, makers of diagnostic imaging hardware and nuclear medicine agents, has moved to acquire cancer drugmaker Progenics Pharmaceuticals in an all-stock transaction.
Progenics officially got a thumbs up from the FDA on its cancer radiation therapy Azedra, sending the New York company’s stock climbing Monday afternoon. The drug was approved to treat rare and extremely lethal adrenal gland cancers for which there was no approved treatments. Until now.
Progenics Pharmaceuticals’s Azedra has picked up the first-ever approvals in two rare tumor types, and it’s got a hefty price tag to match.
Progenics Pharmaceuticals shares soared after its drug Azedra, a new version of the radiopharmaceutical injectable drug iobenguane I-131, was given the green light by the US Food and Drug Administration (FDA).
The U.S. Food and Drug Administration (FDA) approved New York-based Progenics Pharmaceuticals’ New Drug Application (NDA) for Azedra for 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. It is the first and only therapy approved for these indications.
The U.S. Food and Drug Administration (FDA) on Monday approved Progenics Pharmaceuticals Inc’s treatment for two types of rare adrenal gland tumors, making it the first drug approved in the United States for this use.
The First FDA-Approved Treatment for These Rare, Life-Threatening Neuroendocrine Cancers in Patients Aged 12 and Older
SILVER SPRING, Md., July 30, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed (unresectable), have spread beyond the original tumor site and require systemic anticancer therapy. This is the first FDA-approved drug for this use.
The U.S. Food and Drug Administration (FDA) on Monday approved Progenics Pharmaceuticals Inc’s treatment for two types of tumors.