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Advanced Accelerator Applications Lutathera® (lutetium (177Lu) oxodotreotide) for Treatment of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Recommended for NHS Funding in Scotland

Advanced Accelerator Applications
Posted on: 23 Jul 18

Advanced Accelerator Applications, a Novartis company, welcomes the publication of the Scottish Medicines Consortium’s recommendation of Lutathera® (lutetium (177Lu) oxodotreotide), for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.


The SMC has announced today, 9th July, that it has accepted lutetium (177Lu) oxodotreotide as a treatment option in adults for all approved indications of progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs). This means that the treatment will now be available to patients via the NHS in Scotland. The European Commission (EC) approved marketing authorisation of lutetium (177Lu) oxodotreotide in September 2017.


Lutetium (177Lu) oxodotreotide) is a 177Lu-labeled somatostatin analog peptide. It belongs to an innovative form of treatments called Peptide Receptor Radionuclide Therapy (PRRT), which involves targeting tumours with radiolabeled molecules that bind to specific receptors expressed by the tumour.


We are very pleased to receive a positive recommendation from the SMC,” commented Germo Gericke, M.D., Head of Research and Development at Advanced Accelerator Applications. “Lutetium (177Lu) oxodotreotide is the first treatment of its kind to receive regulatory approval and it is our hope that being recognised by the SMC as a cost-effective treatment for all approved indications will facilitate broad availability of this therapy for GEP-NET patients in Scotland.


This positive recommendation is based on key evidence, including the results of a randomised, open label, phase 3 study, NETTER-1, in 229 patients with inoperable, metastatic or locally advanced, progressive midgut NET, which included head to head data comparing lutetium (177Lu) oxodotreotide with a double dose of Octreotide LAR in patients with inoperable midgut NETs progressive under standard Octreotide LAR treatment and overexpressing somatostatin receptors.


The primary outcome was progression-free survival (PFS) which was defined as time from randomisation to disease progression. The median PFS was 28.4 months for lutetium (177Lu) oxodotreotide and 8.5 months in Octreotide LAR.


Quality of Life was also assessed, and results indicate that there were clinically and statistically significant improvements in scores for global health status and diarrhoea and a trend towards improvement in pain scores in the lutetium (177Lu) oxodotreotide group compared to the octreotide LAR group.


Additionally, data to inform efficacy was used from the Erasmus Phase 1/2 trial. This was conducted in more than 1,200 patients with a wide range of NET indications including foregut (pancreatic), midgut and hindgut.


The most common side effects seen with Lutathera treatment are nausea and vomiting, which occurred at the start of the infusions in around half of patients and may be related to the amino acid infusion.2 Other common side effects affecting more than 1 in 10 patients are thrombocytopenia, lymphopenia, anaemia, pancytopenia, tiredness and reduced appetite.


“The NETTER-1 study demonstrates the clinical utility and beneficial nature of lutetium (177Lu) oxodotreotide in treating adults for GEP-NETs,” stated Professor Nicholas Reed, Consultant Clinical Oncologist, at the Beatson Oncology Centre, Glasgow, UK. “This approval is a key milestone for clinicians treating GEP-NETs and means there is a new treatment option available for patients in Scotland who fit the right criteria. This approval in Scotland is strongly welcomed as a positive development in treatment options for people with GEP-NETs.”


GEP-NETs, are a group of tumours originating in the neuroendocrine cells of numerous organs. The estimated incidence of gastrointestinal NETs in the UK is approximately 2.65 per 100,000 per year, while the estimated incidence of pancreatic NETs in the UK is less than 0.2 per 100,000 per year. However, since NETs are often slow-growing and associated with prolonged survival, the prevalence of NETs is relatively high.

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Editor's Details

Natalie Lanyon

Last updated on: 23/07/2018

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