EU approves Lutathera (lutetium 177Lu oxodotreotide) for gastroenteropancreatic neuroendocrine tumors.- Advanced Accelerator Applications.

Advanced Accelerator Applications has announced that the European Commission has approved the marketing authorization of Lutathera (lutetium 177Lu oxodotreotide) for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.

The marketing authorization is based on results of a randomized pivotal Phase III study, NETTER-1 that compared treatment using Lutathera to a double dose of Octreotide LAR in patients with inoperable midgut NETs progressive under standard dose Octreotide LAR treatment and overexpressing somatostatin receptors; as well as efficacy and safety data from a Phase 1/2 trial conducted by Erasmus Medical Center in more than 1,200 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 (Strosberg, et al. N Engl J Med 2017;376:125-35). 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. Although the final Overall Survival analysis (secondary endpoint) is planned for after the first of either 158 cumulative deaths, or five years after the last patient is randomized; the current update (after 71 cumulative deaths), also confirmed the favorable trend of 28 deaths in the Lutathera arm versus 43 in the octreotide LAR 60 mg arm. The median OS in the octreotide LAR arm was 27.4 months, but was still not reached in the Lutathera arm after 42 months, with a Hazard Ratio of 0.536, meaning a reduction of risk of death of 46% using Lutathera compared to octreotide LAR 60 mg).