Lantheus Receives Final FDA Approval for BRAVNETSA™ (Lutetium Lu 177 Dotatate), the Only Radiopharmaceutical FDA has Determined to be Bioequivalent and Therapeutically Equivalent to LUTATHERA® for the Treatment of GEP-NETs

The FDA granted final approval for BRAVNETSA (lutetium Lu 177 dotatate), Lantheus' radioligand therapy for adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, making it the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to Novartis' LUTATHERA. BRAVNETSA, previously referred to as PNT2003, is the first radioligand therapy approved through the FDA's Abbreviated New Drug Application (ANDA) pathway, opening a new regulatory route for follow-on radiopharmaceuticals; U.S. GEP-NET prevalence is estimated at approximately 200,000 patients.

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