For which indications are 177lu Dotatate peptide receptor radionuclide therapy approved by the FDA?

177Lu Dotatate (Lutathera) is a radiolabeled somatostatin analog peptide approved by the FDA in January 2018 for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. Specifically, it is indicated for:

• Unresectable or metastatic GEP-NETs
  
  
  
  
  • This includes foregut, midgut, and hindgut neuroendocrine tumors
  
  


• Positive somatostatin receptor expression on tumor cells
  
  
  
  
  • Confirmed by Ga-68 Dotatate PET/CT scan
  
  

Some key points about the approved use of Lutathera:

• It is not indicated for the treatment of non-GEP neuroendocrine tumors


• Safety and efficacy has not been established for use in pediatric patients

The approval was based on the NETTER-1 phase 3 trial, which demonstrated:

• Significantly longer progression-free survival with Lutathera plus long-acting octreotide compared to high-dose long-acting octreotide alone (PFS not reached vs 8.4 months)


• Objective response rates of 18% with Lutathera vs 3% with octreotide

How Does 177Lu Dotatate Work?

• 177Lu Dotatate consists of the radioisotope lutetium-177 bound to a peptide called Dotatate


• Dotatate allows specific targeting of somatostatin receptor-positive tumors


• When injected, 177Lu Dotatate binds to tumors and delivers targeted radiation, killing cancer cells

Side Effects

The most common side effects of 177Lu Dotatate (reported in ? 20% patients) include:

• Fatigue


• Nausea


• Abdominal pain


• Vomiting

More serious side effects can include:

• Myelosuppression (low blood cell counts)


• Renal toxicity


• Radiation exposure side effects

Careful monitoring of blood cell counts, kidney function, and cumulative radiation dose is important during treatment.

Candidates for 177Lu Dotatate Therapy

The best candidates for 177Lu Dotatate PRRT include those with:

• Inoperable, metastatic GEP-NETs that continue to progress


• Positive somatostatin receptor status on tumor cells


• Good performance status

Dotatate PRRT can provide significant benefit in these patients by stabilizing or shrinking tumors, delaying further progression.

At Hormone Harmony Clinic() Hormone Clinic, we offer cutting edge Peptide Receptor Radionuclide Therapy for neuroendocrine tumors with a highly experienced team of specialists. Contact us today to find out if you may be a candidate for this innovative treatment option.