Curium Wins FDA Approval for First Radioligand Rival

Curium won FDA approval for BEXLUTRY on 14 September 2026, making it the first company to bring what the industry is calling a radioligand “equivalent” to market — a 505(b)(2)-approved rival to Novartis’s decade-old Lutathera, for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. The approval landed three months after a federal court threw out the patents Novartis had used to try to block it.

A dose built to match, not to differ

BEXLUTRY delivers lutetium-177 — a beta-emitting radioisotope — chelated to dotatate, a somatostatin analog that binds to receptors overexpressed on most gastroenteropancreatic neuroendocrine tumors. The radioisotope rides the analog to the tumor and irradiates it from within. Curium’s approved regimen mirrors Lutathera’s established dosing: 7.4 GBq (200 mCi) by intravenous infusion every eight weeks, for four doses, a cumulative 29.6 GBq. FDA approved BEXLUTRY on bridging pharmacokinetic and analytical data referencing Lutathera’s existing efficacy record, not on a new head-to-head trial — the same logic a 505(b)(2) filing is built for, applied here to a radiopharmaceutical for the first time.

What cleared BEXLUTRY’s path

01

A first for the 505(b)(2) pathway

No radioligand therapy had previously reached the U.S. market through a 505(b)(2) filing referencing an approved radiopharmaceutical — Curium’s approval establishes the template other radioligand challengers are likely to follow.

02

A patent fight already won, on paper

A five-day bench trial in the U.S. District Court for the District of Delaware ended in June 2026 with Judge Maryellen Noreika ruling all four patents Novartis and Advanced Accelerator Applications asserted invalid, under the on-sale-bar doctrine, and not infringed. Novartis has appealed; the ruling is not the last word.

03

An existing global radiopharmaceutical network

Curium already manufactures and distributes a broad portfolio of diagnostic and therapeutic radiopharmaceuticals worldwide — the company describes itself as the world’s largest pure-play nuclear medicine company — giving BEXLUTRY a cold-chain and logistics base a single-product entrant would have to build from nothing.

“FDA approval of BEXLUTRY is a defining milestone for Curium as we expand our offering into oncology therapeutics.” Renaud Dehareng, CEO, Curium Group — 14 September 2026 announcement

BEXLUTRY’s approval in four figures

1stradioligand therapy approved as an equivalent via the 505(b)(2) pathway

7.4 GBq(200 mCi) dose, given intravenously every eight weeks

4doses in the approved regimen, a cumulative 29.6 GBq

4Novartis/AAA patents a Delaware court invalidated in June 2026

Figures from Curium's 14 September 2026 announcement and the June 2026 Delaware ruling.

The drug BEXLUTRY has to unseat

Novartis’s Lutathera has held the GEP-NET radioligand market essentially alone since its 2018 approval. Novartis reported $203 million in Lutathera sales for full-year 2025, up roughly 7% (5% at constant currencies), according to the company’s own results release — modest next to Novartis’s broader oncology portfolio, but the entire addressable base BEXLUTRY now competes for. Before radioligand therapy, and still often as a first step, GEP-NET patients are managed on somatostatin analogs such as octreotide or lanreotide, injectable drugs that control hormone-driven symptoms and can slow tumor growth but do not deliver the targeted radiation dose a radioligand does.

PRRT for NETs, two publishers apart

$813M → $3.18B

Global peptide-receptor radionuclide therapy (PRRT) market for neuroendocrine tumors, 2026, as estimated by two different research publishers — a gap wide enough to show how unsettled this category’s sizing still is.

Future Market Insights, 2026$813M

Coherent Market Insights, 2026$3.18B

Sources: Future Market Insights, PRRT market analysis, 2026 · Coherent Market Insights, PRRT market analysis, 2026

Regulatory News outlook

We expect BEXLUTRY to open with roughly $50 million or more of annual U.S. sales within its first two years, well short of unseating Lutathera outright.

How we got here: If Curium captures even a quarter of Lutathera's $203 million in full-year 2025 sales — a plausible early share for a bridging-data entrant without its own head-to-head efficacy trial, competing on price and supply rather than clinical differentiation — that is roughly $50 million; we treat this as a floor, not a forecast, since Novartis's pending appeal adds genuine uncertainty to how freely Curium can market and distribute BEXLUTRY.

GEP-NET treatment, before and after a radioligand

Product	Mechanism	Typical sequencing	U.S. approval status	Administration
BEXLUTRY (Curium)	Lu-177-dotatate radioligand	After progression on somatostatin analogs, alongside Lutathera	FDA approved 14 September 2026	IV infusion, every 8 weeks × 4
Lutathera (Novartis)	Lu-177-dotatate radioligand	After progression on somatostatin analogs	FDA approved 2018	IV infusion, every 8 weeks × 4
Octreotide LAR / lanreotide	Somatostatin analog	First-line, before radioligand therapy	FDA approved (multiple manufacturers)	Intramuscular or subcutaneous injection, monthly

From published labelling and standard treatment sequencing; not a clinical comparison.

From two merged radiopharmacies to an oncology approval

Curium’s road from Belgium and Missouri

1. April 2017

   Curium formed

   IBA Molecular and Mallinckrodt Nuclear Medicine LLC merged to create Curium, a standalone global radiopharmaceutical company.

2. ~2016 onward

   CapVest becomes controlling shareholder

   Private equity firm CapVest Partners has held a controlling stake in Curium since around the time of the merger.

3. November 2025

   Continuation-vehicle recapitalization

   A roughly $7 billion recapitalization brought in ICG, TPG GP Solutions, CVC Secondary Partners, Goldman Sachs Alternatives, Lunate, Pantheon and Ardian as investors.

4. June 2026

   Delaware patent ruling

   A federal court invalidated all four Novartis/AAA patents asserted against Curium's radioligand program, clearing the path to file.

5. 14 September 2026

   BEXLUTRY approved

   FDA approval via the 505(b)(2) pathway, referencing Lutathera.

6. Ahead

   Novartis appeal

   Novartis has appealed the Delaware ruling; the outcome could still affect how BEXLUTRY is marketed and distributed.

What the 14 September announcement does not settle: BEXLUTRY's exact NDA number, which was not yet independently locatable in FDA's public database at publication, and the final outcome of Novartis's appeal of the Delaware patent ruling. Curium's own disclosures, not this article's reporting, will resolve the second; we will update this page when FDA's database indexes the first.

Frequently asked questions

What is BEXLUTRY?

BEXLUTRY (lutetium Lu 177 dotatate injection) is a radioligand therapy for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). FDA approved it on 14 September 2026 through the 505(b)(2) pathway, referencing Novartis's Lutathera.

Is BEXLUTRY a generic version of Lutathera?

Not formally. Curium and much of the trade press describe it as the first approved radioligand 'equivalent,' but it was cleared via a 505(b)(2) application with bridging data rather than the abbreviated new drug application (ANDA) pathway used for a true generic.

How did Curium clear the patent path to approval?

A U.S. District Court for the District of Delaware ruling in June 2026 found all four Novartis/Advanced Accelerator Applications patents Curium was sued over invalid, under the on-sale bar doctrine, and not infringed. Novartis has appealed that ruling.

Who makes Curium?

Curium is a privately held, private-equity-backed radiopharmaceutical company headquartered in Paris, with U.S. operations based in St. Louis, Missouri. It has no public stock ticker.