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For your patients with SSTR+ GEP-NETs, start strong with LUTATHERA. 1st and only radioligand therapy to change the trajectory of GEP-NETs. Trusted by HCPs to treat >18,000 patients in 7 years. Not an actual patient.
FDA approval was based on the efficacy and safety of NETTER-1, a phase 3, randomized, open-label, multicenter study in 229 patients with well-differentiated, grade 1/2 advanced GEP-NETs after SSA progression.2,3,5
 
NETTER-2 was a phase 3, randomized, open-label, multicenter study in 226 patients with metastatic or advanced GEP-NETs.1,6

SUPERIOR EFFICACY IN 2 PHASE 3 TRIALS

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LUTATHERA + SSA demonstrated 3x longer PFS vs SSA alone2,6,7

NETTER-2 primary analysis: mPFS of 22.8 months with LUTATHERA + SSA vs 8.5 months with SSA alone (HR, 0.28 [95% CI, 0.18-0.42]; P<.0001)6

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NETTER-1 primary analysis: mPFS NR with LUTATHERA + SSA vs 8.5 months with SSA alone (HR, 0.21 [95% CI, 0.13-0.32]; P<.0001)2,3

NETTER-1 updated analysis: mPFS of 28.4 months with LUTATHERA + SSA vs 8.5 months with SSA alone (HR, 0.21 [95% CI, 0.14-0.33]; P<.0001)7

ESTABLISHED SAFETY & PROVEN TOLERABILITY

Consistent safety profile with no new safety signals in NETTER-1† and NETTER-2 with 5-year follow-up in NETTER-16,8

  • Most common AEs (≥20%) across trials: nausea, abdominal pain, diarrhea (NETTER-1 and NETTER-2), vomiting, fatigue, thrombocytopenia, and musculoskeletal pain (NETTER-1)2,3,6

  • In NETTER-1 and NETTER-2, respectively: 7% and 2% of patients reduced dose, 5% and 2% of patients discontinued treatment3,6

Choose LUTATHERA: Trusted by HCPs to treat >18,000 patients in 7 years4,5,*

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*Internal data tracking as of May 2025.
 
†Cutoff date for final analysis was January 18, 2021.
 
1L, first line; 2L, second line; AEs, adverse events; CI, confidence interval; FDA, US Food and Drug Administration; GEP-NETs, gastroenteropancreatic neuroendocrine tumors; HCPs, health care professionals; HR, hazard ratio; mPFS, median progression-free survival; NR, not reached; PFS, progression-free survival; SSA, somatostatin analogue; SSTR+, somatostatin receptor-positive.
References: 1. Data on file. Novartis Pharmaceuticals Corp; 2021. 2. Lutathera. Prescribing information. Novartis Pharmaceuticals Corp. 3. Strosberg J, El-Haddad G, Wolin E, et al; for the NETTER-1 trial investigators. Phase 3 trial of Lu-dotatate for midgut neuroendocrine tumors. N Engl J Med. 2017;376(2):125-135. 4. Data on file. LUTATHERA ROME extract. Novartis Pharmaceuticals Corp; May 2025. 5. US Food and Drug Administration. FDA approves lutetium Lu 177 dotatate for treatment of GEP-NETS. Updated January 26, 2018. Accessed June 1, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-dotatate-treatment-gep-nets 6. Singh S, Halperin D, Myrehaug S, et al. [177Lu]Lu-DOTA-TATE plus long-acting octreotide versus high-dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2-3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study. Lancet. 2024;403(10446):2807-2817. 7. Kunz P, Benson A, Bodei L, et al. The phase 3 NETTER-1 study of 177Lu-DOTATATE in patients with midgut neuroendocrine tumours: updated progression-free survival analyses. Poster presented at: North American Neuroendocrine Tumor Society (NANETS) Annual Multidisciplinary Medical Symposium. November 4-6, 2021; Chicago, IL. 8. Strosberg JR, Caplin ME, Kunz PL, et al; NETTER-1 investigators. 177Lu-dotatate plus long-acting octreotide versus high-dose long-acting octreotide in patients with midgut neuroendocrine tumours (NETTER-1): final overall survival and long-term safety results from an open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2021;22(12):1752-1763.