Curium has won full US marketing approval for Bexlutry ([177Lu]oxodotreotide, formerly PNT2003), the first approved generic radioligand therapy (RLT) worldwide and an equivalent to Novartis’ Lutathera for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours in adults and children aged 12 years and older.

The path ran through POINT Biopharma, Lantheus, Eli Lilly’s USD 1.4 billion acquisition of POINT, Curium’s USD 8 billion acquisition of Lantheus’ radiopharma assets, a 2024 ANDA filing, litigation over six Novartis patents, and a June 2026 ruling that all six patents were invalid, converting the tentative approval into a full licence.

Commercially, the approval cracks open a radiopharma market long protected by isotope supply, manufacturing complexity, and method-of-use patents rather than molecule novelty. Lutathera generated USD 816 million in 2025 sales under Novartis after its 2017 EU launch via Advanced Accelerator Applications.