FDA Grants Final Approval of Emerging Radiopharmaceutical for GEP-NET Treatment

The Food and Drug Administration (FDA) has approved Bravnetsa (lutetium Lu 177 dotatate) for the treatment of somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adult patients.

Approved via the FDA’s abbreviated new drug application (ANDA) pathway, the radiopharmaceutical may be utilized in treating foregut, midgut and hindgut tumors, according to Lantheus, the developer of Bravnetsa. The agent previously garnered a tentative approval from the FDA in March 2026.

Noting the challenges with treating the often slow growing tumors, Lantheus said Bravnetsa provides another treatment option for GEP-NETs that reportedly affect nearly 200,000 patients in the United States.

“As the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to Lutathera approved in the United States, Bravnetsa’s approval marks an important milestone for Lantheus as we continue to expand our radiopharmaceutical portfolio, bringing additional treatment options to people living with GEP-NETs,” said Mary Anne Heino, the executive chairperson and CEO of Lantheus.