Curium's BEXLUTRY, a 505(b)(2) lutetium Lu 177 dotatate equivalent, has received FDA approval for somatostatin receptor-positive GEP-NETs in adults.

Lanreotide injection, a generic formulation referencing lanreotide, was approved by the FDA for GEP-NETs management.

The FDA has issued a CRL to the NDA seeking the approval of the investigational agent 177Lu-edotreotide for the treatment of patients with GEP-NETs.

Perspective Therapeutics (NYSE American: CATX) announced that the European Commission has granted orphan medicinal product designation for [212Pb]VMT-α-NET for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs), following a positive opinion from EMA’s Committee for Orphan Medicinal Products.According to the company, this designation may provide protocol assistance, fee reductions and, if [212Pb]VMT-α-NET is approved, up to 10 years of market exclusivity in Europe. The candidate is being evaluated in an ongoing multi-center, open-label Phase 1/2a study (NCT05636618) in patients with unresectable or metastatic SSTR2-positive tumors, with interim clinical data presented at ASCO 2026 and further data submissions planned in 2026–2027.

Lutathera is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (“GEP-NETs”). The...

Lutathera is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (“GEP-NETs”). The...

Lutathera is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (“GEP-NETs”). The...

Lutathera is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (“GEP-NETs”). The...

Nature Reviews Clinical Oncology, Published online: 16 July 2026; doi:10.1038/s41571-026-01187-2Second-line 177Lu-edotreotide shows promise in GEP NETs

Parham Habibzadeh: How the COMPETE Trial Could Reshape Treatment Sequencing for Progressive GEP-NETs / Alexandre Teulé, Andreas Buck, Andreas Kluge, Anja

Results of the Phase III COMPETE clinical trial show that the targeted radiotherapeutic agent [177Lu]Lu-edotreotide significantly prolonged progression-free survival in patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) compared with targeted therapy with everolimus.

Results of the Phase III COMPETE clinical trial show that the targeted radiotherapeutic agent [177Lu]Lu-edotreotide significantly prolonged progression-free survival in patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) compared with targeted therapy with everolimus.

Update 4th July 2026. Data from the Phase 3 COMPETE trial - ITM11 Lu-edotreotide led to statistically significant and clinically meaningful improvements in progression-free survival. Efficacy and harms results support the use of Lu-edotreotide in early lines of therapy in patients with advanced, progressive GEP NETs. Bonus info about other trials for NET: 1.  There is also an ITM11 product on trial for more aggressive G2/G3 GEPNETs known as COMPOSE - click here 2.  An ITM11 product trial for Lung and Thymic NETs is running and currently in Phase 3 - known as LEVEL - …

Update 1st July 2026. This approval was being held up by legal processes after a patent dispute brought by Novartis subsidiary Advanced Accelerator Applications over their respective lutetium-177 (Lu-177) dotatate products.   However, a court victory on 17th June 2026 paves the way for Curium’s plans to provide targeted radioligand therapy to U.S. patients with GEP-NETs.  A new PDUFA (Prescription Drug User Fee Act) is awaited. (St. Louis. – 09 July 2024) – Curium, a world leader in nuclear medicine, announced today that it has submitted its 505(b)(2) New Drug Application for Lutetium Lu 177 Dotatate PRRT, which, if approved by the U.S.

JONESBORO, Ark. (June 19, 2026) – St. Bernards Healthcare has successfully administered an innovative targeted cancer therapy to its first patient this week, making it the only health system in Northeast Arkansas to offer this level of cancer care. The therapy, LUTATHERA® (lutetium Lu 177 dotatate), helps patients facing a rare cancer diagnosis, known as gastroenteropancreatic neuroendocrine tumors (GEP-NETs). These cancers develop in the stomach, intestines or pancreas, and can be difficult to treat with standard, more traditional cancer therapies.

University of Michigan researchers have identified a new target that can suppress tumor growth. Their findings may lead to new treatment methods for gastroenteropancreatic neuroendocrine tumors.

Shubham Pant, MD, MBBS, discusses recent treatment advancements across gastrointestinal malignancies.

Shubham Pant, MD, MBBS, discusses recent treatment advancements across gastrointestinal malignancies.

Cao et al. demonstrate synthetic lethality between PIKfyve and mTOR signaling in GEP-NETs. PIKfyve sustains ferritinophagy and limits lipid synthesis, whereas mTOR promotes lipogenesis and suppresses ferritinophagy. Dual inhibition disrupts lysosomal degradation, lipid metabolism, and iron metabolism, causing metabolic collapse and tumor cell death—a potential therapeutic strategy for GEP-NETs.