First PRRT Approved by U.S. FDA

New treatment for GI and pancreatic NETs

The U.S. Food and Drug Administration (FDA) has approved Peptide Receptor Radionuclide Therapy (PRRT) with a new radiopharmaceutical for certain neuroendocrine tumors. Lutetium 177 DOTA-TATE (Lu 177), a type of PRRT, is now approved for the treatment of somatostatin-receptor-positive neuroendocrine tumors in the gastrointestinal (GI) tract or pancreas in adults.

FDA approval of PRRT using Lu-177 will allow more eligible U.S. patients to receive this “life extending” treatment. Lu-177 is manufactured by Advanced Accelerator Applications (AAA), a Novartis company. Prior to the FDA approval, PRRT with Lu-177 was only available in a limited number of American treatment centers as part of an expanded access program or through a clinical trial.

What is PRRT?

“Wider access to new therapies is one of the major concerns expressed by patients in surveys supported by the Neuroendocrine Tumor Research Foundation (NETRF),” said Elyse Gellerman,  NETRF Chief Executive Officer. “Today’s ruling by the FDA will give more people living with gastroenteropancreatic NET cancer access to a treatment that may help extend their lives.”

PRRT Benefits

The approval is based on results of a randomized pivotal Phase 3 clinical trial, NETTER-1, which compared Lu-177 with the standard of care in 229 patients. Close to 80 percent of patients receiving Lu-177 went longer periods of time without tumor growth (called progression-free survival) compared to patients receiving the standard of care. Thirteen percent of Lu-177 patients experienced complete or partial tumor shrinkage.

PRRT Side Effects

Common side effects of Lu-177  include low levels of white blood cells, high levels of enzymes in certain organs, vomiting, nausea, high levels of blood sugar, and low levels of potassium in the blood. Serious side effects include low levels of blood cells, development of certain blood or bone marrow cancers, kidney damage,  liver damage, and abnormal hormones levels.

Finding PRRT Treatment Centers

Patients and family members considering this therapy should talk to their treatment team to see if they are eligible for this therapy and to discuss the pros and cons of PRRT.  If you don’t have a NET cancer treatment provider, search here for a specialist or multi-disciplinary treatment program. To find a PRRT facility near you, check out Northern California CarciNET Community ‘s list of treatment centers offering PRRT. With every newly approved therapy, it is also important to talk to your health insurance provider to determine your insurance coverage.

NETRF PRRT Research

PRRT treatment options beyond Lu-177 are already under investigation for NETs, giving this nuclear medicine modality a promising future. NETRF is currently funding research to further advance PRRT. One NETRF-funded study uses different radionucleotides (Lead investigator: Brian Untch, MD; Memorial Sloan Kettering), another injects the treatment into arteries (Lead investigator: Tom Hope, MD; Univesity of California, San Francisco), instead of veins, to reduce radiation exposure to the kidneys and other organs. After undergoing PRRT, the kidneys process urine, which contains radioactive elements from the treatment. NETRF’s research is made possible by charitable gifts from generous individuals and family foundations who want to advance treatments for this rare disease.

Learn more about PRRT

  • NETRF has featured information about PRRT in its free patient and family conferences. See recordings of NETRF’s PRRT patient talks in this playlist on YouTube
  • Society of Nuclear Medicine and Molecular Imaging Fact Sheet
  • Search for a nuclear imaging and therapy treatment center near you
  • Sign up to learn about other advancements in NETs
  • See more information about NET treatments
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Sherry

Yes, please send me more articles on this and additional research.

estela

What do you do when the insurance is not paying for the treatment and I don’t have the cash money for it. My husband’s doctor did recommend him to Excel Diagnostics Nuclear Orology Center where they are offering that treatment and my husband was a good candidate for it. we have appealed it with our insurance “Cigna” but Cigna rejected.

Ruth

I am a primary NET Lung, when can we get access to PRRT?

Deborah

My husband is also a lung NET. He is on his 13th round of cap/tem. He had shrinkage until his last CAT scan 3 months ago which showed stability. There may be a spot in his intestine but Stanford is still not sure. He has mets to liver and some sternal lymph nodes. Stanford would like to take him off chemo for awhile to give him a break. If you don’t mind, can you email me with your journey please? deborahjv@aol.com. We are very interested in PRRT.

Mayank

My brother is diagnosed with undifferentiated extrapulmonary small cell neuroendocrine carcinoma. Please contact me.I am interested in participating in clinical trials if any for extrapulmonary NETs.

Liz

Any case reports of acute urinary retention following PRRT?

Theressa

My husband has NETs. 8 spots in his liver and one close to his Pancreas. He’s doing hormone therapy. We would like more information. His is 56 and has always on had 3% body mass so he’s in great shape. Was diagnosed in September 2017. Dr says he’s doing well the spots seem to be shrinking. He’s writing a book.

Karen

My older brother (64 yr) has pancreatic NET with liver mets and a met wrapped around the outside of his colon. He has paraneoplastic syndrome with constant dizziness and ataxia. Would this therapy help him? He currently lives in Canada. Would it be available there?

First PRRT Approved by U.S. FDA