LUTATHERA®, 370 MBq/mL, solution for infusion is a ready-to-use product, indicated for the treatment of resectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP NETs) in adults.
The pivotal phase III study NETTER-1 compared 177Lu-DOTATATE and octreotide LAR 60 mg (double label dose) in patients with locally advanced or metastatic inoperable, grade 1 or grade 2 neuroendocrine tumors of the small intestine, progressing under treatment with octreotide LAR 20-30 mg every 21 to 28 days. The study showed a statistically significant 82% reduction in the risk of progression or death (Median PFS: octreotide LAR, 8.5 months LUTATHERA®, not reached.
Hazard ratio: 0.18 (95% CI: [0.11-0.29] p<0.0001). In the LUTATHERA® arm, patients also experienced an overall response rate of 18% (vs 3% in comparator arm p=0.0008) which is rarely seen with systemic therapies in the NETs population. LUTATHERA® demonstrates a favorable safety profile, with rare clinically relevant findings.
For more information see Summary of product characteristics (SmPC). http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004123/human_med_002163.jsp&mid=WC0b01ac058001d124