Prescribing information (external link)

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Hero banner. LUTATHERA® (lutetium [177Lu] oxodotreotide) logo.

Guidelines

LUTATHERA® (lutetium [177Lu] oxodotreotide) is indicated for the treatment of unresectable or metastatic, progressive, well-differentiated (G1 and G2), somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.1

LUTATHERA® Summary of Product Characteristics (SmPC) can be found here

European guidelines recommend LUTATHERA® after progression on first line somatostatin analogues (SSAs)1–7

European Society of Nuclear Medicine (EANM) logo.

European Association of Nuclear Medicine (EANM)

EANM Focus 32

 

Peptide receptor radionuclide therapy (PRRT) is recommended as second-line treatment after progression or lack of symptomatic control on non-radiolabelled SSTR agonists, for patients with non-resectable or disseminated gastrointestinal NETs.

European Neroendocrine Tumour Society (ENETS) logo.

European Neuroendocrine Tumor Society (ENETS)

 

ENETS 20243

 

  • For non-resectable locally advanced or metastatic small intestine NET grade 1/2 (functional and non-functional), PRRT is recommended as a second-line therapy if SSTR imaging is positive3

  • For non-resectable locally advanced or metastatic small intestine NET grade 2 (functional and non-functional) with rapid progression and/ or high tumour burden, PRRT is recommended as a first-line therapy if SSTR imaging is positive.3 This recommendation is off-license, please note Novartis does not endorse the off-license use of LUTATHERA® as a first-line therapy

  • For advanced non-functional pancreatic NET grade 1/2, PRRT is recommended as a second-line therapy if SSTR imaging is positive4

  • For functional pancreatic NET, PRRT is recommended as a second- or third-line therapy, dependent on hormonal symptoms5

  • For non-resectable metastatic colorectal NET grade 1/2 (asymptomatic, low grade, low tumour burden, slow growth, Ki67 ≤10%), PRRT is recommended as a second-line therapy if SSTR imaging is positive6

For the LUTATHERA® indication and prescribing information, please see the top of this page.

European Society for Medical Oncology (ESMO) logo.

European Society for Medical Oncology (ESMO)

 

ESMO 2020 update7

 

  • PRRT is recommended as a second-line therapy in patients with midgut NETs after progression on SSAs who fulfil the general requirements for PRRT

  • In pancreatic NETs, PRRT should be used after failure of approved therapies

Note, before starting treatment with LUTATHERA®, SSTR imaging (scintigraphy or positron emission tomography) must confirm the overexpression of these receptors in the tumour tissue, with the tumour uptake at least as high as normal liver uptake.1

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EANM, European Association of Nuclear Medicine; ENETS, European Neuroendocrine Tumor Society; ESMO, European Society for Medical Oncology; GEP-NET, gastroenteropancreatic neuroendocrine tumour; NET, neuroendocrine tumour; PRRT, peptide receptor radionuclide therapy; RLT, radioligand therapy; SmPC, summary of product characteristics; SSA, somatostatin analogue; SSTR, somatostatin receptor. 

References

  1. LUTATHERA® Summary of Product Characteristics.

  2. Ambrosini V, et al. Eur J Cancer 2021;146:56–73.

  3. Lamarca A, et al. J Neuroendocrinol 2024;36(9):e13423.

  4. Kos-Kudła B, et al. J Neuroendocrinol 2023;35(12):e13343.

  5. Hofland J, et al. J Neuroendocrinol 2023;35(8):e13318.

  6. Rinke A, et al. J Neuroendocrinol 2023;35(6):e13309.

  7. Pavel M, et al. Ann Oncol 2020; 31(7):844–860.

 

UK | December 2025 | FA-11462543-1

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.