Lantheus Holdings wins FDA approval for Bravnetsa before Curium vote

The U.S. list of approved treatments for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours grew on Tuesday after Lantheus Holdings, Inc. NASDAQLNTH said the FDA granted final approval to Bravnetsa, a radiopharmaceutical equivalent to Lutathera. The decision moves abbreviated application 217060 beyond tentative approval, giving Lantheus an approved adult cancer therapy as it prepares for a vote on its sale to privately held Curium.

The company's release says Bravnetsa, previously called PNT2003, was approved under an abbreviated new drug application after the FDA found it bioequivalent and therapeutically equivalent to the reference product Lutathera. Lantheus did not announce a launch date or price.

Lantheus is a Bedford, Massachusetts, developer and seller of radiopharmaceutical imaging agents and cancer treatments, with a pending sale to Curium.

Lantheus shares NASDAQLNTH closed unchanged at US$100.00 on Nasdaq at 4 p.m. EDT on Sept. 22, the day of the announcement. A Sept. 8 merger proxy says Curium would pay US$102.50 a share in cash at closing, with additional contingent payments possible if specified sales targets are met.

Adult Label Leaves Launch Timing Open

The FDA's Feb. 27, 2026, tentative-approval letter identified the application as ANDA 217060 and found Bravnetsa equivalent to the reference product. The September final 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 adult-only label has a boundary: Lutathera also carries a pediatric indication, but Bravnetsa's prescribing information omits that use because of the reference maker's pediatric marketing exclusivity. The approval therefore gives Lantheus access to the adult market without extending its label to children.

Bravnetsa's safety information warns of cumulative radiation exposure, bone-marrow suppression and kidney injury. Those are labeling warnings for lutetium Lu 177 dotatate treatment; the release presented no new clinical comparison with Lutathera.

“We are focused on a thoughtful launch and ensuring the right commercial and operational capabilities are in place to support reliable supply and broad patient access,” Lantheus executive chair and chief executive Mary Anne Heino said in the release.

The incumbent, Novartis AG SWXNOVN NYSENVS, reported US$225 million in Lutathera sales for the second quarter of 2026. That July 21 figure gives a measure of the existing market, though Lantheus has not disclosed a revenue forecast for Bravnetsa. Mugglehead previously covered a separate Novartis actinium-based cancer drug trial.

Read more: Novartis advances actinium-based cancer drug after promising trial data

Curium received FDA approval on Sept. 14 for Bexlutry, another adult GEP-NET treatment using lutetium Lu 177 dotatate, and said it was already available. Curium's product came through a separate 505(b)(2) application supported by bridging data, while Bravnetsa has the agency's explicit therapeutic-equivalence determination under an abbreviated application.

Among listed developers, Perspective Therapeutics, Inc. NYSEAMERICANCATX is testing a different radioactive medicine against somatostatin receptor-positive neuroendocrine tumours. The company scheduled updated VMT-alpha-NET data for Oct. 23 at the ESMO Congress; that program remains investigational.

The iShares Biotechnology ETF NASDAQIBB closed at US$210.81 on Sept. 22 at 4 p.m. EDT, up 1.76 per cent that day. The benchmark's movement provides sector context for the Sept. 22 session.

The Curium Vote Is Next

The merger proxy sets US$102.50 per share as the cash consideration and up to US$12 more through contingent value rights. Its specified sales milestones cover prostate cancer diagnostics, neurology diagnostics and the DEFINITY ultrasound product. Bravnetsa is outside those defined groups, so this approval does not itself trigger a contingent payment.

Curium's own Bexlutry approval means the proposed buyer and Lantheus now hold separate U.S. authorizations for treatments aimed at the same adult GEP-NET population. The companies have not said how they would position the two products together if the transaction closes, which is expected in the first half of 2027 subject to conditions.

Lantheus shareholders are scheduled to vote on the Curium merger on Oct. 14. That vote will decide whether the agreed cash-and-contingent-rights transaction can proceed while the timing and terms of Bravnetsa's launch remain undisclosed.