FDA approves first radioligand equivalent drug, Curium’s Bexlutry

The U.S. Food and Drug Administration (FDA) has approved the industry’s first radioligand equivalent drug.

According to Fierce Pharma on the 15th (local time), the FDA approved Curium’s lutetium Lu 177 dotatate injection, Bexlutry. The treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) references Novartis’ Lutathera.

Like Lutathera, Bexlutry targets somatostatin receptors to deliver radioactive material and is indicated for patients with somatostatin receptor-positive GEP-NETs.

The approval was granted through the 505(b)(2) pathway, which allows the use of data from previously approved drugs. Curium applied for approval in July 2024, and the approval process moved forward after a court dismissed all of Novartis’ patent infringement claims in June.

Bexlutry’s approval marks an opportunity for Boston-based nuclear medicine company Curium, which has focused on diagnostic imaging, to expand into therapeutics. Curium is in the process of acquiring Lantheus for up to $8 billion; Lantheus received tentative FDA approval in March for PNT2003, a generic version of Lutathera.

Curium CEO Renaud Dehareng said, “We will apply the same discipline and commitment to radioligand therapy that have built trust over decades.”

Lutathera, meanwhile, generated $436 million in sales for Novartis in the first half of this year after becoming the first radioligand therapy approved in January 2018.

Novartis CEO Vas Narasimhan said during the company’s second-quarter earnings call on July 2 that “the radioligand copy market will operate differently from the traditional generic and biosimilar markets because of logistical complexity and physicians’ expectations for on-time delivery.” He added, “We mitigated the impact of the generic launch with our broad supply chain.”