Curium enters radioligand therapy market with FDA approval of Bexlutry

USA—The US Food and Drug Administration (FDA) has approved Bexlutry, the industry’s first generic radioligand therapy, marking Curium’s entry into the therapeutic nuclear medicine market.

Developed by Curium, Bexlutry is a lutetium-177 dotatate injection that references Novartis’ Lutathera, which is approved to treat gastroenteropancreatic neuroendocrine tumors (GEP NETs).

Like Lutathera, Bexlutry targets somatostatin receptors on tumor cells and delivers a radioactive payload to SSTR-positive tumors.

FDA approval pathway

The FDA approved Bexlutry through the 505(b)(2) pathway, a regulatory route that allows manufacturers to rely partly on data from previously approved medicines while providing additional information to support a new application.

The approval follows a legal dispute between Curium and Novartis.

Curium submitted its application in July 2024, while Novartis challenged the product over patent infringement.

A court decision in June cleared Curium of the patent claims, allowing the FDA to proceed with its review.

Meanwhile, Lantheus received tentative FDA approval in March for PNT2003, another Lutathera copy, through the abbreviated new drug application pathway.

Curium is also pursuing the acquisition of Lantheus in a transaction valued at up to US$8 billion.

Curium expands into radioligand therapy

Bexlutry expands Curium’s business beyond diagnostic imaging and into radioligand therapy.

The Boston-based company already markets Detectnet, a diagnostic imaging agent used to identify somatostatin receptor-positive neuroendocrine tumors.

“For decades, Curium has earned trust in nuclear medicine through reliability, quality and day-in, day-out delivery,” Curium CEO Renaud Dehareng said.

“We are applying that same discipline and commitment to help eligible NET patients access radioligand therapy with confidence.”

Mike Patterson, Curium’s North American head, said the company would now focus on launching Bexlutry with support from its nuclear medicine infrastructure.

“Our priority now is a high-quality launch supported by our end-to-end nuclear medicine infrastructure, designed to help ensure consistent delivery, predictable scheduling support for sites of care, and a dependable experience for patients receiving radioligand therapy,” Patterson said.

Competition with Lutathera

The FDA approved Lutathera in January 2018 as the first radioligand therapy. Novartis reported US$436 million in Lutathera sales during the first half of 2026.

However, Novartis CEO Vas Narasimhan said during the company’s second quarter earnings call in July that competition from radioligand copies could differ from traditional generic competition because of the logistical requirements involved in delivering these medicines.

Narasimhan said Novartis expected its global supply network and ability to deliver treatments on schedule to reduce the impact of new competition, including products entering the market at lower prices.

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