logo
Plus   Neg
Share
Email

Novartis:FDA Approves Lutathera For Gastroenteropancreatic Neuroendocrine Tumors

Novartis AG (NVS) announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and Drug Administration (FDA) approval of its new drug application or NDA for Lutathera for treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors, in adults.

Lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications) — a somatostatin analog peptide designed to target tumors with radiolabeled molecules that bind to specific receptors expressed by the tumor — is the first radiopharmaceutical approved for the treatment of gastroenteropancreatic neuroendocrine tumors.

Lutathera, which received orphan drug designation from the FDA, is a first-in-
class drug and the first available FDA-approved Peptide Receptor Radionuclide
Therapy (PRRT), a form of treatment comprising of a targeting molecule that
carries a radioactive component.

The approval was based on a Phase 3 study which demonstrated a 79% reduction in the risk of disease progression or death within the Lutathera plus best standard of care arm (octreotide LAR 30mg every four weeks) compared to 60 mg of octreotide LAR alone (hazard ratio 0.21, 95% CI; 0.13-0.32; p<00.001).

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Electronics retailer Best Buy Co. Inc. (BBY), Wednesday said it has agreed to buy GreatCall Inc. for $800 million in cash. GreatCall is a provider of connected health and personal emergency response services to the aging population, with more than 900,000 paying subscribers. It offers easy-to-use... Rio Tinto PLC (RIO) is reportedly seeking to divest its Canadian iron-ore business for a possible consideration worth $6 billion. According to Sky News, the Anglo-Australian mining giant has begun courting potential bidders for its $6 billion Canadian iron-ore? operations as it seeks to take advantage... Brewer Constellation Brands Inc. will invest C$5 billion, or $4 billion, in Canadian cannabis company Canopy Growth Corp. as part of an expansion of the two companies' strategic partnership, the companies said Wednesday. Canopy Growth is Canada's largest medical marijuana producer. Shares of Canopy Growth are gaining more than 27 percent in the regular trading.
Follow RTT