The FDA has approved the industry’s very first generic radioligand therapy, known as a radioligand equivalent.
Curium’s lutetium Lu 177 dotatate injection, Bexlutry, won that title by referencing Novartis’ Lutathera for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Like Novartis' Lutathera, Bexlutry targets the somatostatin receptor to deliver a radioactive payload and is therefore indicated for SSTR-positive GEP-NETs.
Bexlutry got its approval through the FDA’s 505(b)(2) pathway, which is a hybrid new drug application process that allows for reliance on existing data from previously approved reference drugs.
Beyond Bexlutry, Lantheus in March won an FDA tentative approval for its PNT2003, a Lutathera generic, under the abbreviated new drug application pathway. Curium is in the process of acquiring Lantheus for up to $8 billion.
Curium got Bexlutry past the FDA after winning a tough legal battle. Curium filed for approval in July 2024, and the FDA moved after a court decision this past June cleared the company of all patent infringement claims brought by Novartis.
Bexlutry’s approval marks a milestone for Curium, expanding the Boston-based nuclear medicine company beyond its traditional diagnostic imaging business and into therapeutics. The company’s diagnostic portfolio includes Detectnet, which helps locate SSTR-positive neuroendocrine tumors.
“For decades, Curium has earned trust in nuclear medicine through reliability, quality and day-in, day-out delivery. We are applying that same discipline and commitment to help eligible NET patients access radioligand therapy with confidence,” Curium CEO Renaud Dehareng said in a statement.
“Today’s FDA approval brings us a step closer to advancing our ambition of aiming to improve the lives of up to 80% of patients with cancer,” Curium’s North American head, Mike Patterson, said in a statement. “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.”
Approved by the FDA in January 2018 as the first radioligand therapy, Lutathera generated $436 million sales for Novartis in the first half of 2026.
Speaking to investors on the company’s second-quarter earnings call in July, Novartis CEO Vas Narasimhan suggested that the radioligand copycat market will behave differently than the generics and biosimilars markets, “just given the logistical complexity and as well the expectation that physicians have that the medicines is delivered on time each time, given the nature of the logistics for the office.”
“We do believe that given our extensive network of supply and our ability to deliver on time in full to physicians across the globe, but also across the U.S., we've mitigated impact from a generic launch, even with a lower price being brought into the market,” he said.