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2017: First Radioligand therapy (RLT) approved in Europe for the treatment of gastroenteropancreatic neuroendocrine tumours – Lutathera®

18/06/2021

Nominated by: Novartis

Organisations in nomination: Novartis

Gastroenteropancreatic neuroendocrine tumours are a rare type of cancer that can form in the pancreas or in other parts of the gastrointestinal tract, including the stomach, small intestine, colon, rectum and appendix.

Radio Ligand Therapy (RLT) is a form of precision medicine that, when introduced in the bloodstream, binds to specific receptors over-expressed by certain cancer cells, causing DNA damage that can inhibit cell growth and replication and potentially trigger cell death.

Lutathera served as a proof of concept for targeted RLT, demonstrating the feasibility of delivering radiation directly to tumour cells.

When first approved by the European Commission in 2017, Lutathera® represented the first registered Peptide Receptor Radionuclide Therapy (PRRT), a form of Radioligand Therapy (RLT) that combines a targeting molecule and a radioactive isotope.

Investigation into potential utility of radioligand therapy in other solid tumours has made significant advances since 2017.  March 2021 data from the Phase III clinical trial VISION study from Novartis in metastatic castration-resistant prostate cancer, showed positive results for both primary endpoints of overall survival and radiographic progression-free survival.

Technologies such as PRRT hold the promise to target hard to treat cancers, such as advanced prostate cancer, and extend treatment efficacy and survival.

References:

  • Strosberg J, El-Haddad G, Wolin E, et al. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med 2017; 376:125-35.
  • Strosberg J, Wolin E, Chasen B, et al. Health related quality of life in patients with progressive midgut neuroendocrine tumors treated with 177Lu-Dotatate in the phase III NETTER-1 Trial. JCO 2018
  • Lutathera, European Medicines Agency website

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Alexandra Simionca
Alexandra Simionca
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