FDA Approves Lutetium Lu 177 Dotatate for Gastroenteropancreatic Neuroendocrine Tumors

The US Food and Drug Administration (FDA) approved lutetium Lu 177 dotatate (¹⁷⁷Lu-dotatate) for the treatment of patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) — the first treatment specifically for this indication.¹

¹⁷⁷Lu-dotatate binds to somatostatin receptors to deliver radiation directly into tumor cells.

The FDA based its approval on 2 clinical studies. In the phase 3 NETTER-1 study (ClinicalTrials.gov Identifier: NCT01578239), researchers randomly assigned 229 patients with somatostatin receptor–positive GEP-NETs to receive octreotide LAR with or without ¹⁷⁷Lu-dotatate.²

By the time of data cutoff, patients in the ¹⁷⁷Lu-dotatate arm had a 20-month progression-free survival of 65.2% compared with 10.8% among patients who received octreotide LAR alone. The ¹⁷⁷Lu-dotatate and the control groups had response rates of 18% and 3%, respectively (P < .001). Patients in the ¹⁷⁷Lu-dotatate arm also had a lower risk of tumor growth and mortality compared with patients who received octreotide LAR only.

For the second study, 1214 patients with somatostatin-positive tumors, including GEP-NETs, were assigned to receive ¹⁷⁷Lu-dotatate. Of the 360 patients with GEP-NETs, 16% demonstrated a complete or partial shrinkage of their tumor.

The most frequently reported serious adverse events with ¹⁷⁷Lu-dotatate include myelosuppression, secondary myelodysplastic syndrome and leukemia, renal toxicity, hepatotoxicity, neuroendocrine hormonal crises, and infertility.

Reference

1. FDA approves new treatment for certain digestive tract cancers [news release]. Silver Springs, MD: US Food and Drug Administration; January 26, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm594043.htm. Accessed January 26, 2018.
2. Strosberg J, El-Haddad G, Wolin E, et al. Phase 3 trial of 177Lu-Dotatate for midgut neuroendocrine tumors. N Engl J Med. 2017;376(2):125-35. doi: 10.1056/NEJMoa1607427