Novartis Leads Drug Approval NewsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Novartis.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday January 24, 2018 date to Tuesday January 30, 2018.
Novartis Gets FDA Approval for Cancer Radiopharmaceutical
The US Food and Drug Administration (FDA) has approved Lutathera (lutetium Lu 177 dotatate), a radiopharmaceutical for treating certain digestive tract cancers, from Advanced Accelerator Applications (AAA), a subsidiary of Novartis.
Novartis acquired AAA, a Saint-Genis-Pouilly, France-headquartered radiopharmaceutical company, for $3.9-billion in January 2018. AAA develops, produces, and commercializes molecular nuclear medicines, including Lutathera.
Lutathera is a radioactive drug that works by binding to a part of a cell called a somatostatin receptor, which may be present on certain tumors, according to information from the FDA. After binding to the receptor, the drug enters the cell allowing radiation to cause damage to the tumor cells. It was approved for treating a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Radiopharmaceuticals, such as Lutathera, are medicinal formulations containing radioisotopes, which are used clinically for diagnosis and therapy, according to Novartis. AAA also develops, manufactures, and commercializes companion diagnostics for Lutathera (Netspot and SomaKit TOC). AAA had sales of EUR 109 million ($126 million) in 2016.
Lutathera was approved in Europe in September 2017 for treating unresectable or metastatic, progressive, well-differentiated (G1 and G2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.