Cancer Treatment Today

Gastroenteropancreatic neuroendocrine tumors (GEP-NET) are a rare group of cancers that affects the pancreas or different parts of the gastrointestinal tract, such as the stomach, intestines, colon and rectum. Approximately one of 27,000 people are diagnosed with GEP-NET each year. GEP-NETs have limited treatment options after initial therapy fails to keep the cancer from growing. Lutathera® (Lutetium Lu 177 Dotatate) is the first radioactive drug, or radiopharmaceutical, that has been approved for the treatment of GEP-NETs. More spefically Lutathera® is indicated for adult patients with somatostatin receptor-positive GEP-NETs, including foregut, midgut and hindgut neuroendocrine tumors. Lutathera received an orphan drug designation and is also the first available FDA approved Peptide Receptor Radionuclide Therapy (PRRT), a form of treatment comprising of a targeting molecule that carries a radioactive component. The safety and effectiveness of Lutathera® (Lutetium Lu 177 Dotatate) for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults has been evaluated in a multi-center open label phase 3 trial the NETTER-1 trial and the Erasmus retrospective study. Based on the clinical data from these two trials the evidence is sufficient to determine that this technology results in meaningful improvement in net health outcomes for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut (gastroduodenal), midgut (distal small intestine and proximal colon), and hindgut (distal colorectal and pancreas) neuroendocrine tumors in adults.

Lutathera® (Lutetium Lu 177 Dotatate) was FDA approved January 2018 for the treatment of somatostatin receptor-positive gastroenteropacreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

CLINICAL / MEDICAL REFERENCES

• Food and Drug Administration NDA Approval for Lutathera (lutetium Lu 177 dotatate) Reference ID 4212675

• Strosberg J, El-Haddad G, Wolin E. et. al. Phase 3 Trial of Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med 376;2 January 12, 2017

• Brabander T, van der Zwan WA, Teunissen JJM, et. al. Long-Term Efficacy, Survival and Safety of Lu DOTA, Tyr Octreotate in Patients with Gastroenteropancreatic and Bronchical Neuroendocrine Tumors. Clin Cancer Res 2017 Aug 15; 23(16):4617-4624. PMID 28428192