The Food and Drug Administration has approved a new radioligand therapy for adults with a rare group of digestive-system tumors, giving patients and prescribers a second source of a treatment that had previously come from a single manufacturer.
The agency cleared Bexlutry (lutetium Lu 177 dotatate), made by the radiopharmaceutical company Curium, on September 14 for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, or GEP-NETs — tumors that arise from hormone-producing cells scattered through the stomach, intestines and pancreas and account for roughly 60% to 70% of all neuroendocrine tumors.
How the therapy works
Bexlutry is a radioligand therapy: it binds to somatostatin receptors that are common on the surface of GEP-NET cells and delivers targeted radiation directly to the tumor, sparing more of the surrounding healthy tissue than conventional radiation. The drug reached the market through the FDA's 505(b)(2) pathway, an approval route that let Curium rely on published evidence and targeted bridging studies showing the drug has a similar biological and chemical profile to Lutathera, the lutetium Lu-177 dotatate radioligand therapy that has been available since 2018. The agency and company describe Bexlutry as the first approved "radioligand equivalent" for GEP-NETs, effectively a second, independently manufactured version of an already-established cancer treatment.
FDA approval of BEXLUTRY is a defining milestone for Curium as we expand our offering into oncology therapeutics.
Renaud Dehareng, Group Chief Executive Officer, Curium
Company leadership framed the approval as much about supply as about science: with a second manufacturer now producing the same class of radioligand therapy, hospitals and cancer centers may have more reliable access to a treatment that depends on specialized radioactive isotopes with short shelf lives and complex logistics.
Real risks that come with real radiation
Because Bexlutry delivers therapeutic radiation, its label carries substantial warnings. Curium's prescribing information lists risks of myelosuppression (drops in blood cell counts), a 2% to 2.3% incidence of secondary myelodysplastic syndrome or leukemia, kidney and liver toxicity, hypersensitivity reactions, and embryo-fetal harm. Cumulative radiation exposure from the therapy can also cause temporary or permanent infertility in both men and women, and patients are counseled on radiation-safety precautions during and after treatment.
Bexlutry is now available for prescribing physicians and patients, according to Curium, making it the company's first FDA-approved radioligand therapy. Whether the added competition affects pricing or wait times for patients with these rare tumors will likely become clearer as cancer centers begin incorporating the new option alongside Lutathera in the coming months.
