Drugs

FDA Accepts ITM’s NDA for Radiopharmaceutical

FDA has accepted for review an ITM Isotope Technologies NDA for 177Lu-edotreotide (ITM-11), a targeted radiopharmaceutical therapy for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 177Lu-edotreotide is described by the company as a no-carrier-added lutetium-177–based radiotherapeutic designed to deliver targeted radiation to somatostatin receptor–positive tumors. The agency has set a user fee review action target date for 8/28/2026.

The submission is based on data from the Phase 3 COMPETE open-label trial that enrolled 309 patients with inoperable, progressive Grade 1 or Grade 2 GEP-NETs. The study compared 177Lu-edotreotide with everolimus, a standard targeted therapy.

The company says COMPETE met its primary endpoint, showing a significant improvement in median progression-free survival for patients treated with ITM-11 versus everolimus. Investigators also reported a higher objective response rate in the radiopharmaceutical arm, it says.

ITM says it is also studying 177Lu-edotreotide in COMPOSE, another Phase 3 trial evaluating the agent in patients with well-differentiated, aggressive Grade 2 or Grade 3 somatostatin receptor–positive GEP-NETs.

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