Lutetium Dotatate LU-177

iStock, Love Employee While Novartis’ Pluvicto is a blockbuster, Curium heads into talks with the FDA about the review of its rival drug candidate believing a competing product can make the supply chain more resilient. Novartis has turned Pluvicto into a dominant prostate cancer product in the four years since its first FDA approval, growing sales to $1.3 billion in the first half of 2026, up more than 50% from the same period of 2025. Despite the presence of a well-established incumbent, Curium is betting that there is an opportunity for a second drug—and has identified its decades of radiopharmaceutical manufacturing experience as a resource that could help it unlock the market. “People are looking for more options,” Michael Patterson, North America CEO at Curium, told BioSpace . “We hear it from physicians, we hear it from patients.” Novartis’ Pluvicto is a radioligand therapy (RLT) that binds to PSMA to deliver lutetium-177 (Lu-177) to prostate tumors. By targeting an antigen found on prostate cancer cells, the therapy delivers cytotoxic doses of the radioactive substance without causing intolerable damage to healthy cells. The product is a clinical and commercial success and a key pillar of Novartis’ leadership of the RLT market, but Curium sees room for a second PSMA-directed Lu-177 RLT. Having ceded a head start to Novartis, many developers of PSMA-directed RLTs are trying to differentiate their candidates by delivering actinium-225 (Act-225), an isotope that emits more energy than Lu-177 over a smaller area. AstraZeneca and Eli Lilly scooped up Act-225-based Pluvicto challengers by acquiring Fusion Pharmaceuticals and POINT Biopharma, respectively. Lantheus tried to mount a more direct challenge to Pluvicto, paying POINT $250 million for an RLT that delivers Lu-177 to cells expressing PSMA. However, the company, which agreed to merge with Curium in an $8 billion deal this month, axed plans to seek FDA approval for the asset after seeing Phase 3 data. The Lantheus decision and the broader industry’s focus on Act-225 leave Curium as the best-placed company to launch a direct rival to Pluvicto. A Phase 3 trial of Curium’s candidate, 177Lu-PSMA-I&T, met its primary endpoint in 2024. Curium is now “allowing that data to mature and preparing to work with the FDA in terms of filing, timing, etc. , and the review process,” Patterson said. Subscribe to Manufacturing Brief! Get a weekly update including our take on the most critical issues impacting manufacturing. June 12, 2025 Read more Betting on manufacturing muscle Curium was created in 2017 through the merger of IBA Molecular and Mallinckrodt Nuclear Medicine, companies that had more than a century of collective experience in the nuclear industry. The company will likely be “the only vertically integrated manufacturer of radioligand therapy” if its RLT candidate comes to market, Patterson said. Novartis initially struggled to meet demand for Pluvicto, which was in short supply for part of 2023. The company added production lines in New Jersey and an RLT plant in Indiana, enabling it to meet demand since the FDA classified the shortage as resolved in October 2023. Pluvicto has stayed off the FDA’s drug shortage list despite Novartis contending with rising demand for a product with specific requirements. Lu-177 has a half-life of 6.7 days, preventing companies from stockpiling RLTs and forcing them to adopt a just-in-time manufacturing model. The lack of a buffer means manufacturing problems can quickly translate to product shortages. While Novartis has now successfully met demand for years, Patterson said that Curium can “put some resiliency into this market from a supply chain perspective.” Manufacturing Radiopharmaceutical Sector Shapes Supply Chain Around Fast-Decaying Products The necessity of delivering medicine days after it’s produced drives decisions about where to build facilities and how to ship radioactive materials to healthcare providers. February 24, 2026 · 3 min read · Nick Paul Taylor Read more The University of Missouri Research Reactor currently supports the U.S. market for Lu-177. Curium has “multiple lines to make our own lutetium,” Patterson said, as well as partnerships with multiple reactors around the world. The Curium executive sees benefits to having in-house capacity for isotope production and each subsequent step in the supply chain. “Controlling your own isotope production puts you in a position to flex and adapt to the needs of the marketplace,” Patterson said. “We’ll have multiple manufacturing lines at our Indiana facility, which puts some backup options there as well. So, if there is a need for additional material or products, we’ll be able to flex at both the isotope level as well as at the manufacturing level.” Delivering data to drive demand Curium has distribution capabilities and “very good relationships with nuclear medicine departments” that Patterson sees as additional strengths the company can leverage if it wins FDA approval. The short shelf life of RLTs makes distribution particularly important for the modality, with companies needing to move products quickly from plants to patients, either over land or by air. “A truck is often the most reliable because you control it completely. If we can truck and drive the doses to the location, we prefer to do that,” Patterson said. “We’ll utilize couriers for the last phase to get the dose to physicians.” Yet while RLTs and other drug modalities have different manufacturing and supply chain requirements, Curium’s chances of entering the market and growing sales ultimately rest on the same source that shapes all R&D programs and launches: data. “Physicians will look at the data,” Patterson said. “First and foremost, they’re going to look at the data on the product, and they’re going to look at the ability to supply their patients reliably.”