FDA Approves LUTATHERA® for Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors

BREAKING NEWS: On January 26, 2018 the US Food and Drug Administration approved LUTATHERA® marking the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).  The drug will be used in Peptide Receptor Radionuclide Therapy (PRRT), which is a form of targeted treatment.  LUTATHERA® (lutetium Lu 177 dotatate) is indicated for adult patients with somatostatin receptor-positive GEP-NETs, including foregut, midgut, and hindgut neuroendocrine tumors.

Click here to read the FDA press release about the approval: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm594043.htm

Click here to read the Advanced Accelerator Applications press release about the approval: http://www.adacap.com/wp-content/uploads/2018/02/AAA-Lutathera-FDA-Approval-PR_2018-01-26-FINAL-2.pdf

The approval of LUTATHERA® is based on results from the NETTER-1 clinical study. Click here to read the article in the New England Journal of Medicine about the NETTER-1 study: http://www.nejm.org/doi/full/10.1056/NEJMoa1607427?query=featured_home&

Click here to read more about PRRT from the Society of Nuclear Medicine and Molecular Imaginghttp://www.snmmi.org/AboutSNMMI/Content.aspx?ItemNumber=5691.

Topics Covered:

  • What is peptide receptor radionuclide therapy (PRRT) and how does it work?
  • What conditions are treated with PRRT?
  • How is PRRT performed?
  • What are the advantages of PRRT?
  • Is PRRT safe?
  • Side effects
  • Home care
  • Is PRRT covered by insurance?
  • What’s new in PRRT research and development?

Additional publications about PRRT with Lutathera are available from Advanced Acclerator Applications by clicking the links below:

A Fact Sheet with basic “quick” info on Lutathera/PRRT

A brochure giving high level information on Patient Assistance Programs available through AAA PatientCONNECT™

A brochure with information about Lutathera, including some details regarding administration and follow up procedures and other helpful hints (including a brief mention of Patient Assistance Programs available via AAA PatientCONNECT™)

A Journey of Hope: Moving Toward a Brighter Future in Neuroendocrine Tumor (NET) Treatment. A newly-released, must-read about five neuroendocrine tumor patients, each with different experiences with Peptide Receptor Radionuclide Therapy (PRRT). With a foreword, “Hope is Like Air,” by neuroendocrine cancer specialist Eric Liu, MD, general surgeon, Rocky Mountain Cancer Centers, Denver, Colorado.



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