SMC recommends Lutathera ® for treatment of GEP-NETs

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.

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.

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 median progression-free survival (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.

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.

Germo Gericke, M.D., Head of Research and Development at Advanced Accelerator Applications commented, “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.”