Lantheus gains FDA approval for Bravnetsa in GEP-NET
核心洞察
The FDA granted final approval to Lantheus's Bravnetsa (搜索), a lutetium Lu 177 dotatate (搜索) radiopharmaceutical, for adults with somatostatin receptor (搜索)-positive gastroenteropancreatic neuroendocrine tumours (搜索).
Bravnetsa (搜索), formerly PNT2003, was cleared under abbreviated new drug application 217060 after the FDA found it bioequivalent and therapeutically equivalent to Lutathera.
The adult-only label omits Lutathera's pediatric indication because of the reference maker's pediatric marketing exclusivity, and Lantheus disclosed no launch date or price.
Lantheus Holdings (搜索) said the FDA granted final approval to Bravnetsa (搜索), a radiopharmaceutical equivalent to Lutathera, for adults with somatostatin receptor (搜索)-positive gastroenteropancreatic neuroendocrine tumours (搜索). The decision moves abbreviated new drug application 217060 beyond the tentative approval letter issued Feb. 27, 2026, which identified the application and found the product equivalent to the reference product. Bravnetsa, previously called PNT2003, was approved after the FDA found it bioequivalent and therapeutically equivalent to Lutathera. The September decision authorizes marketing for adults with receptor-positive tumours of the pancreas or gastrointestinal tract, including foregut, midgut and hindgut disease. It is an equivalence finding, not evidence that Bravnetsa outperforms Lutathera.
The label covers adults only. Lutathera also carries a pediatric indication, but Bravnetsa (搜索)'s prescribing information omits that use because of the reference maker's pediatric marketing exclusivity. Safety information warns of cumulative radiation exposure, bone-marrow suppression and kidney injury, labeling warnings for lutetium Lu 177 dotatate (搜索) treatment. Lantheus did not announce a launch date or price. Executive chair and chief executive Mary Anne Heino said the company is focused on a thoughtful launch and on ensuring the commercial and operational capabilities for reliable supply and broad patient access.
Novartis reported US$225 million in Lutathera sales for the second quarter of 2026, a measure of the existing market, while Lantheus has not disclosed a revenue forecast for Bravnetsa (搜索). Curium (搜索) received FDA approval on Sept. 14 for Bexlutry (搜索), another adult GEP-NET treatment using lutetium Lu 177 dotatate (搜索), cleared through a separate 505(b)(2) application supported by bridging data. Lantheus shareholders vote on the proposed Curium merger on Oct. 14; the proxy sets US$102.50 per share in cash plus up to US$12 through contingent value rights tied to prostate cancer diagnostics, neurology diagnostics and DEFINITY milestones, which exclude Bravnetsa. Perspective Therapeutics is testing VMT-alpha-NET against somatostatin receptor (搜索)-positive neuroendocrine tumours, with updated data scheduled for Oct. 23 at the ESMO Congress.
Read more: Lantheus wins FDA approval for Bravnetsa GEP-NET drug