Second Lutathera Rival Approved: Lantheus's Bravnetsa Wins Final FDA Nod Eight Days After Curium's Bexlutry — and Curium Is Buying Lantheus

Second Lutathera Rival Approved: Lantheus's Bravnetsa Wins Final FDA Nod Eight Days After Curium's Bexlutry — and Curium Is Buying Lantheus

Update, September 23, 2026. On September 22, 2026, the FDA granted final approval to Lantheus Holdings' Bravnetsa (formerly PNT2003; lutetium Lu 177 dotatate) under ANDA 217060, converting its February 27, 2026 tentative approval. The FDA found Bravnetsa bioequivalent and therapeutically equivalent to the reference product Lutathera (Novartis) for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (pancreatic and GI tract, including foregut, midgut, and hindgut disease). The label is adult-only — Lutathera's pediatric indication is omitted because of the reference maker's pediatric marketing exclusivity. Lantheus announced no launch date and no price.

This is the second Lutathera rival approved in eight days, and the two arrived by different abbreviated routes. Per Mugglehead's report: "Curium received FDA approval on Sept. 14 for Bexlutry, another adult GEP-NET treatment using lutetium Lu 177 dotatate... 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." Lantheus executive chair and CEO Mary Anne Heino: "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."

The twist: the two rivals are about to have the same owner. Lantheus is pending acquisition by Curium at $102.50/share in cash (plus up to $12 more in contingent value rights), with the shareholder vote set for October 14, 2026 and closing expected in H1 2027. Curium — which already owns Bexlutry — would therefore hold both U.S.-authorized Lutathera equivalents¹; the companies have not said how they would position the two products. Bravnetsa sits outside the CVR's defined sales-milestone groups, so the approval triggers no contingent payment. Market context: Novartis reported $225 million in Lutathera sales for Q2 2026.

What it means: the "radioligand equivalent" concept — generic-style competition in radiopharmaceuticals, long thought impractical — is now established with two entrants inside a single week (Telix to Acquire ITM for $1.65B — a Radiopharma Consolidation Built Around ITM-11, the Drug the FDA Just Rejected is the parallel consolidation wave in radiopharma). The immediate open questions are Bravnetsa's launch timing/price and whether an Oct 14 shareholder vote hands both products to one company.