international specialist in Molecular Nuclear Medicine, Advanced Accelerator Applications (AAA), has announced that the European Commission (EC) has approved the marketing authorisation 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 approval allows for the marketing of Lutathera® in all 28 European Union member states, as well as Iceland, Norway and Liechtenstein.
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.
Lutathera® has received orphan drug designation from the European Medicines Agency.
The approval is based on results of a randomised pivotal Phase 3 study, NETTER-1, that compared treatment using Lutathera® with a double dose of Octreotide LAR in patients with inoperable midgut NETs progressive under standard Octreotide LAR treatment and overexpressing somatostatin receptors; as well as efficacy and safety data from a Phase 1/2 trial conducted at Erasmus Medical Center in more than 1200 patients with a wide range of NET indications including foregut (including bronchial and pancreatic), midgut and hindgut.
The European Medicines Agency requested an update of NETTER-1 efficacy results with a cut-off date of June 30, 2016. The findings of this update were consistent with previously published results.
The NETTER-1 study met its primary endpoint, showing a reduction of risk of progression or death of 79% using Lutathera® compared to octreotide LAR 60 mg.
Martyn Caplin, Professor of gastroenterology and GI neuroendocrinology at the Royal Free London and University College London and Vice Chair (former Chairman) of the European Neuroendocrine Tumor Society, said: “There are very few effective treatment options for patients with inoperable, advanced GEP-NETs who are progressive on somatostatin analogues. Having this therapy approved and available will offer physicians a further option to help manage their patients’ disease.”