FDA Approves Lutetium Lu 177 Dotatate for Gastroenteropancreatic Neuroendocrine Tumors

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

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

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