BRAVNETSA (Lutetium Lu 177 Dotatate)

September 22, 2026: Lantheus Holdings, Inc. (NASDAQ: LNTH) announced FDA final approval of BRAVNETSA (lutetium Lu 177 dotatate), approved via the ANDA pathway as a bioequivalent and therapeutically equivalent radiopharmaceutical to LUTATHERA. BRAVNETSA is indicated for adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs.

The company said BRAVNETSA is the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to LUTATHERA in the U.S., and described it as the first radioligand therapy approved through the ANDA pathway. Lantheus said it is preparing a launch and building commercial and operational capabilities to support supply and access; availability timing was not specified.

The release also included safety information based on lutetium Lu 177 dotatate data, including myelosuppression in NETTER-1 and risks such as secondary myelodysplastic syndrome/leukemia, renal toxicity, hepatotoxicity, hypersensitivity, neuroendocrine hormonal crisis, embryo-fetal toxicity, and infertility. Common grade 3-4 adverse reactions listed were lymphopenia, increased GGT, vomiting, nausea, increased AST/ALT, hyperglycemia, and hypokalemia.