The FDA has approved lutetium Lu-177 dotatate injection (Bexlutry), a new option for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Bexlutry is a radioligand equivalent (RLE), a form of PRRT (peptide receptor radionuclide therapy) that shares the same active ingredient, dosing, administration, and expected efficacy and side effects as an already-approved lutetium radioligand therapy.
The approval draws on established clinical evidence for Lu-177 DOTATATE, including the NETTER-1 and ERASMUS studies, along with additional data supporting Bexlutry’s application.
Additional treatment options like this can help support the needs of a growing radioligand therapy field, including patient access, expanded provider choice, and manufacturing capacity and supply reliability.
Bexlutry works by delivering targeted radiation directly to tumor cells. Patients should discuss radioligand therapy with their doctors to understand the benefits and risks of the treatment, including radiation exposure, myelosuppression, secondary blood cancers, and kidney toxicity.
NETRF welcomes the availability of another FDA-approved formulation of Lu-177 DOTATATE for patients with GEP-NETs.
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Learn More about Radiopharmaceutical Treatments
NETWise Episode 44: Radiopharmaceutical Treatment – FAQs & Insights