Drugs

Novartis Touts Positive Lutathera Phase 3 Data

Novartis says the Phase 3 NETTER-2 trial met its primary endpoint of improvement in progression-free survival and the key secondary endpoint of objective response rate in patients with Grade 2 and 3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who received first-line treatment with Lutathera in combination with long-acting octreotide, versus high-dose octreotide alone. The company says the results will be discussed with FDA to determine whether it should seek the drug’s approval in newly diagnosed patients living with advanced GEP-NETs.

FDA approved Lutathera (lutetium Lu 177 dotatate) in 2018 for treating GEP-NETs that are positive for the hormone receptor somatostatin, including GEP-NETs in the foregut, midgut, and hindgut. The agency at the time said it was the first radiopharmaceutical approved for treating the tumors. The drug works by binding to a part of a cell called a somatostatin receptor, which may be present on certain tumors, according to the agency. After binding to the receptor, the drug enters the cell allowing radiation to cause damage to the tumor cells.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome