Adults with a rare group of cancers that begin in the pancreas, stomach, or intestines now have a second FDA-approved source of a targeted radiation drug. The FDA approved Bexlutry (lutetium Lu 177 dotatate injection), made by nuclear medicine company Curium, for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, or GEP-NETs, OncLive reported on September 14.
The approval covers tumors arising in the foregut, midgut, and hindgut. Bexlutry is not a new kind of treatment. It is a radioligand equivalent of Lutathera, the first radioactive drug approved for these tumors, and it was cleared through a pathway supported by published evidence and bridging data showing a similar biological and chemical profile, according to Curium's announcement.
For patients and families, that distinction matters. A second approved product could give treatment centers another supply option for a therapy that depends on tightly scheduled delivery. It does not change who qualifies, and it adds no new evidence that the treatment works better.
A Second Version of a Therapy Doctors Already Use
Curium called Bexlutry the first radioligand equivalent approved for GEP-NETs in adults and said it is now available for prescribing. The company submitted its application in July 2024 under the FDA's 505(b)(2) pathway, which lets a company rely partly on existing data, and said it had designed its formulation to avoid infringing patents listed with the FDA, according to a Curium statement at the time.
When the FDA approved Lutathera on January 26, 2018, Dr. Richard Pazdur, director of the agency's Oncology Center of Excellence, said, "GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing," according to an oncology approval summary citing the agency.
Bexlutry is labeled for adults only. Lutathera's label also includes pediatric use information, and Bexlutry's prescribing information says that information is left off because of the original maker's marketing exclusivity rights.
Curium says GEP-NETs account for 60 to 70 percent of all neuroendocrine tumors, which arise from specialized cells found throughout the body's organs.
How Tumor-Targeted Radiation Works
Many neuroendocrine tumors carry somatostatin receptors on their surface. Lutetium Lu 177 dotatate binds to those receptors and is taken into the cells, where radiation from lutetium-177 damages receptor-positive cells and nearby cells. This approach aims radiation mainly at the tumors rather than spreading it evenly through the body.
Eligibility depends on confirming that a tumor carries these receptors, which is usually done with specialized imaging. The label's recommended dose is 7.4 GBq (200 mCi) every eight weeks, give or take a week, for a total of four doses. Patients receive an amino acid infusion before, during, and after each dose to lower the radiation dose to the kidneys, along with anti-nausea medicine and long-acting octreotide injections on a set schedule. Treatment is given by health care providers trained and licensed to handle radioactive drugs.
The Data Behind the Approval and Its Limits
The efficacy data for GEP-NETs come from ERASMUS, a study in which the drug was first given through an expanded-access program at a single site in the Netherlands. A drug-specific protocol written after the study began did not set a sample size or a plan for testing hypotheses, OncLive reported.
Of 1,214 patients treated, 360 had GEP-NETs and long-term follow-up. In that group, 17 percent had tumors shrink enough to count as a response, including three complete responses, and responses lasted a median of 35 months.
This is single-arm, largely retrospective evidence, not a new randomized trial of Bexlutry. The approval rests on showing that Bexlutry matches the drug already on the market. The label also describes NETTER-1, a randomized trial of 229 patients with advanced midgut tumors. In that trial, lutetium Lu 177 dotatate plus long-acting octreotide cut the risk of disease progression or death by 79 percent compared with high-dose octreotide alone. The trial's final analysis found no statistically significant difference in overall survival between the two groups.
Readers should also note that the claims about reliable supply and scheduling come from Curium, which stands to profit from the product.
Side Effects, Costs, and Questions for the Care Team
The label carries serious warnings. Bexlutry adds to lifetime radiation exposure, which is linked to a higher cancer risk, and radiation can be detected in urine for up to 30 days, so patients receive instructions to protect household members. In NETTER-1, anemia occurred in 81 percent of patients receiving the drug with octreotide and low platelet counts in 53 percent, though severe cases were rare.
Myelodysplastic syndrome, a bone marrow disorder, developed in 2.3 percent of NETTER-1 patients who received the drug, over a median follow-up of 76 months. In ERASMUS, 2 percent developed myelodysplastic syndrome and 0.5 percent developed acute leukemia. Kidney failure, liver injury, allergic reactions including angioedema, and hormone surges causing flushing, diarrhea, and low blood pressure were also reported.
The drug can harm a fetus and may cause infertility. The label advises women who could become pregnant to use effective birth control during treatment and for seven months after the last dose, and men with female partners who could become pregnant to do so for four months. It also advises against breastfeeding during treatment and for 2.5 months after the last dose. Patients must be monitored for at least two hours after each infusion for signs of a severe allergic reaction, in a setting equipped for resuscitation.
Curium's announcement did not include a price. Patients whose doctors recommend radioligand therapy can ask whether their insurer covers both products, whether prior authorization is required, and which version the treatment center uses. The label says long-acting somatostatin analogs must be stopped at least four weeks before each dose and short-acting octreotide at least 24 hours before, so patients should not change those medicines without guidance from their oncology team.
Useful questions include how many doses are planned, how blood counts and kidney and liver function will be monitored, and what radiation precautions apply at home. Patients who develop signs of infection, unusual bleeding or bruising, or signs of kidney or liver problems after treatment should contact their care team promptly.
Curium says its priority now is a high-quality launch with consistent delivery and scheduling support for treatment sites. Whether a second supplier improves access or lowers costs will become clear only as centers begin using it. For now, Bexlutry widens the supply of an established treatment without changing the evidence behind it.
Key Questions Answered
What did the FDA approve? Bexlutry, a lutetium-177 dotatate injection from Curium, for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut tumors.
Is this a new type of cancer treatment? No. It is a radioligand equivalent of Lutathera, which the FDA approved in January 2018. It was cleared through the 505(b)(2) pathway based on published evidence and bridging data.
Who is eligible? Adults whose GEP-NETs are confirmed to carry somatostatin receptors. Bexlutry's label does not include children.
How well does it work? In ERASMUS, 17 percent of the 360 patients with GEP-NETs had tumor shrinkage that counted as a response, and responses lasted a median of 35 months. That study had no comparison group.
What are the main risks? Low blood counts, bone marrow disorders and leukemia in a small share of patients, kidney and liver injury, allergic reactions, hormone crises, fetal harm, and possible infertility.
How much does it cost? Curium has not announced a price. Patients should ask their insurer and treatment center about coverage and prior authorization.
Should patients stop their octreotide shots before treatment? Only under their oncology team's direction. The label requires stopping long-acting somatostatin analogs at least four weeks before each dose and short-acting octreotide at least 24 hours before. This article is general information and is not medical advice.
