If you or a loved one has gastroenteropancreatic neuroendocrine tumors (GEP-NETs), you may be interested in learning about treatment options. One medicine you might hear about is Lutathera (lutetium lu 177 dotatate).
Lutathera was first approved by the FDA in 2018 for use in adults with GEP-NETs. In 2024, it was also approved for adolescents with this condition. It belongs to a class of radioactive medicines called peptide receptor radionuclide therapy (PRRT). Lutathera works by delivering radiation directly into tumors, which can slow or stop them from growing.
GEP-NETs are rare types of tumors in the stomach, intestines, or pancreas. They start in neuroendocrine cells, which are cells that make hormones.
Below are common questions and answers about Lutathera for the treatment of GEP-NETs.
Is Lutathera Right for Me?
To find out if Lutathera is right for treating your gastroenteropancreatic neuroendocrine tumors (GEP-NETs), your health care provider will do scans to see exactly where your tumors are and other tests to learn more about them.
The FDA approved Lutathera for adults and children ages 12 years and older to treat GEP-NETs that meet the following criteria.
Somatostatin receptor-positive. This means the tumor cells have high levels of somatostatin receptors. A somatostatin receptor is a protein on the surface of cells that connects to a hormone called somatostatin, which helps regulate other hormones in the body.
Gut tumors. This medicine is approved for treating GEP-NETs found in certain areas of the digestive tract, including the esophagus, stomach, pancreas, or intestines. Your health care provider may describe the affected area as the foregut, midgut, or hindgut.
Your health care provider can review your test results along with your health history to see if Lutathera is right for you.
How Does Lutathera Work for Neuroendocrine Tumors?
Somatostatin receptors are found on many types of cells, but some neuroendocrine tumors (NETs) have more somatostatin receptors than normal. This makes them a target for treatments like Lutathera.
Lutathera works by targeting a specific type of somatostatin receptors, called subtype 2 somatostatin receptors, or SSTR2 for short. After Lutathera attaches to these receptors, the medicine gets absorbed into the cell and releases a dose of radiation that damages the tumor cell and nearby cells. This can help slow or stop the growth of NETs.
How Do I Use Lutathera?
Lutathera is typically given as an intravenous (IV) infusion once every eight weeks for a total of four doses. You will receive your doses at a hospital, clinic, or treatment center. The Lutathera infusion usually takes 30 to 40 minutes.
Lutathera is a type of radionuclide therapy. It must be prepared and given by health care providers who are specially trained and experienced to safely handle medicines that have radioactive components (radiopharmaceuticals). You cannot store or use it at home.
How Was Lutathera Studied for GEP-NETs?
The safety and effectiveness of Lutathera was studied in two clinical trials. One study, NETTER-1, involved 229 adults with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Everyone had tumors with the following traits when they joined the study:
- Everyone had GEP-NETs in the middle area of their digestive tract (midgut).
- Their tumors could not be surgically removed.
- Their tumors were getting worse and growing (which are signs of disease progression) despite treatment with octreotide, a medicine commonly used for this condition.
People in the NETTER-1 study were randomly assigned to receive either Lutathera and octreotide or octreotide alone. Both groups knew which treatment they were receiving. The main goal of the study was to measure how long the tumors stopped growing after treatment, a measure called progression-free survival. This measure helps show how well a medicine works to slow the progression, or worsening, of a disease.
The people in both treatment groups of NETTER-1 had similar traits. The median age was 64, meaning half were older than 64 and half were younger, with ages ranging from 28 to 87. About half (51%) were male. Everyone was in the United States or Europe. Most of the people were White (82%), while 4% were Black, 3% were Hispanic or Latino, less than 1% were Asian or other, and race information was not reported for 9%.
Another study, ERASMUS, looked at the effect of Lutathera in adults with GEP-NETs in other parts of the digestive system – not just the middle gut area. Everyone in this study received Lutathera along with octreotide. The main goal was to see how many people had their tumors shrink or stop growing.
In total, 1,214 people received Lutathera, and 578 had their tumors assessed at the start of the ERASMUS study. Of those, 360 had GEP-NETs and were followed long-term. Half of the people were older than 60 years, and half were younger, with ages ranging from 30 to 85. About half (51%) were male. Race information was not reported.
What Are the Main Benefits of Lutathera Based on Studies?
The main benefit of Lutathera is that it can help slow the growth of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Two clinical trials support Lutathera as an effective treatment for GEP-NETs. Some of the main results of these studies are described below.
The NETTER-1 clinical trial showed that Lutathera and octreotide worked better than octreotide alone to slow tumor growth.
- The median progression-free survival for the Lutathera group was not reached, meaning that more than half of the people who received Lutathera did not have tumor growth at the time of analysis. But it was estimated to be over 18 months. In contrast, half of those in the octreotide-only group had their cancer get worse (progress) after 8.5 months.
- Lutathera treatment was shown to lower the chance of the tumors getting worse by 79%.
- At month 20, more than 65% of people who received Lutathera had not progressed, compared to about 11% of people who received octreotide alone.
The ERASMUS study also showed positive results, as follows.
- About 17% of people had their tumors respond or shrink after Lutathera treatment. A few people had complete responses, meaning their tumors could no longer be seen on scans.
- Out of the 60 people who responded to treatment, half of them had a response that lasted at least 35 months.
Together, these studies support Lutathera as an effective treatment for GEP-NETs. Your results may be different from what was seen in studies.
How Do I Know if Lutathera Is Working?
Your health care provider will track your progress with regular imaging scans and tests to see how well Lutathera is working and whether your tumors are shrinking or staying the same size. Even if your tumors do not shrink, the medicine may still be working. It is designed to slow tumor growth.
But individual results can vary. In clinical trials, some people had a stable disease, meaning their tumors stopped growing for a while, while others saw their disease progress. In a few cases, the tumors disappeared and were no longer visible on scans. Ask your health care team when to get your first imaging scan after Lutathera treatment and how often they plan to recheck you.
What Is Its Place in Therapy?
An ideal way to manage neuroendocrine tumors (GEP-NETs) is early surgical removal, before the tumors spread. But many people are diagnosed after the tumors have already spread, making complete removal impossible. When complete surgical removal is not an option, medications usually become a key part of managing GEP-NETs.
A type of medicine called a somatostatin analog, such as octreotide, is typically prescribed to help slow or stop GEP-NETs from producing hormones, which can reduce symptoms like diarrhea. They also help to control tumor growth. But if your tumors continue to grow while you’re using this type of medicine, Lutathera may be considered as a treatment option.
Lutathera works differently from octreotide. While octreotide helps control hormone production and symptoms, Lutathera is designed to target and deliver radiation directly into tumor cells. It binds to specific receptors on the tumors and releases radiation inside the cells, which helps slow or stop tumor growth. This makes Lutathera a more targeted treatment for tumors that continue to grow despite treatment with somatostatin analogs like octreotide.
What Should I Expect With Lutathera Infusions?
Lutathera is typically given as an intravenous (IV) infusion for a total of four doses, given eight weeks apart. Your health care provider will give you medications before, during, and after each dose to help reduce the side effects. Your experience may vary, but the following guidelines are provided by the maker of Lutathera.
Before treatment. Long-acting octreotide must be stopped at least four weeks before starting Lutathera. Short-acting octreotide may be continued as needed, but it should be stopped 24 hours before your Lutathera treatment. You will likely receive an injection of long-acting octreotide four to 24 hours after each Lutathera dose to help manage symptoms. It is important to avoid long-acting octreotide within four weeks before the next Lutathera dose. Short-acting octreotide may also be used for symptom control but must be stopped 24 hours before each infusion.
Medications during treatment. Shortly before your Lutathera dose, you will receive anti-nausea medication (antiemetics) and an amino acid solution to protect your kidneys. You will get the amino acid solution through an IV starting 30 minutes before the Lutathera infusion and continue for at least three hours after. If you get serious side effects, your health care provider may adjust your dosage or treatment plan.
Monitoring for reactions. Your health care team will monitor you closely for at least two hours after each infusion to check for any allergic reactions. Your treatment will take place in a hospital or other health care facility where you can be monitored and, in case of serious reactions, receive care right away. Some people have a short stay in the hospital to receive Lutathera, especially for their first dose.
After treatment. For the first two days after your Lutathera dose, your urine (pee) will contain high levels of radioactive material. These hygiene tips can help reduce the risk of radiation exposure to those around you:
- Wash your hands thoroughly after using the toilet.
- Flush the toilet twice after each use.
- If possible, use your own bathroom while other household members use a separate one.
- If you are incontinent, your health care provider may suggest using a catheter for two days after treatment.
- Caregivers should wear protective gloves and clothing when providing close care or handling urine bags.
Radiation can be found in the urine for up to 30 days after treatment. To protect others, your health care provider may give you more safety guidelines to follow at home. Other guidance may include keeping your distance from others for a few days and avoiding close contact with young children and pregnant people.
After completing treatment with Lutathera, which is usually a series of four doses, your health care provider may recommend continuing treatment with long-acting octreotide. If so, they will tell you how often to use it and when to stop it.
Is Lutathera Safe for Children?
In April 2024, the FDA expanded its approval of Lutathera to include children 12 and older with gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
This approval was based on a small study involving nine adolescents with somatostatin receptor-positive tumors, including some with GEP-NETs. They received Lutathera every eight weeks for up to four doses, the same as the adult dosage. The safety of Lutathera in children 12 and older was found to be similar to that in adults. Talk with your health care provider about whether Lutathera is the right choice for your child.
What Types of Drug Interactions Can Happen With Lutathera?
Somatostatin analogs, like octreotide, can interfere with how well Lutathera works because both medicines attach to the same receptors (special surface proteins) on tumor cells. To prevent this, your health care provider will have you stop long-acting somatostatin analogs at least four weeks before each Lutathera dose and short-acting versions at least 24 hours before. Shortly after each Lutathera dose is given, these medications can be used as directed to help manage symptoms.
Also, high doses of steroids (glucocorticoids), such as prednisone, can reduce the number of receptors that Lutathera targets on tumors. So it is important to avoid frequent or high-dose steroids during Lutathera treatment to ensure the medicine works as well as possible.
Is There Any Cost Assistance Available?
A cost assistance program is available from Novartis, the maker of Lutathera, that may reduce the amount you pay. Whether you qualify to enroll may depend on the type of insurance you have or if you are uninsured.
Visit www.lutathera.com/patient-support/novartis-patient-support for more information about Lutathera costs and copay savings. You can also call the drugmaker at 844-638-7222 to connect with a representative for financial support information and other resources.
