Curium Won FDA Approval for Radioligand Therapy

The approval of Bexlutry shifts supply chain competition for healthcare providers managing radioligand therapy.

Updated on Sept. 29, 2026 in Healthcare

Curium Won FDA Approval for Radioligand Therapy

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In September 2026, the FDA approved Curium’s radioligand therapy Bexlutry, marking a new milestone in the rapidly expanding market for specialized cancer treatments. The move highlights increasing industry efforts to scale the delivery of isotope-based therapies as demand continues to outpace available treatment capacity.

Why it matters

Radioligand therapy market growth is currently constrained by complex logistics and limited site capacity, leading to patient wait times of two to six weeks. Controlling the supply chain for materials like lutetium-177 is now a central strategic priority for manufacturers aiming to reduce these bottlenecks.

Lutathera and Pluvicto sales reached $1.7 billion in the first half of 2026, while the number of treatment centers surged to 700 from 86 in November 2022. Manufacturers are competing for supply capacity for lutetium-177, which has a half-life of only 6.7 days.

The players

Curium

A global provider of radiopharmaceuticals formed through a 2017 merger that specializes in the production and logistics of isotope-based therapies.

Novartis

A multinational pharmaceutical company that dominates the radioligand therapy market through products like Pluvicto and Lutathera.

Telix Pharmaceuticals

A clinical-stage biopharmaceutical company that recently agreed to a $1.65 billion buyout of ITM Isotope Technologies Munich.

The details

Delivering radioligand therapies requires a specialized logistics network involving truck routes and air charters to accommodate the short half-life of isotopes like lutetium-177. Beyond material supply, facility expansion is a major hurdle, as sites must be equipped with radiation shielding and dedicated medical teams. Curium, formed from a 2017 merger, is attempting to scale its infrastructure to support 100,000 patients globally within five years by leveraging production capacity in Europe.

Timeline

  1. 2017: Curium was created through the merger of IBA Molecular and Mallinckrodt Nuclear Medicine.

  2. 2023: Novartis added manufacturing capacity for Pluvicto in New Jersey.

  3. 2024: Curium secured isotope production capacity via partnerships in the Netherlands and France.

  4. H1 2026: Novartis products Lutathera and Pluvicto generated $1.7 billion in sales.

  5. September 2026: Curium received FDA approval for Bexlutry.

Market Landscape

The radioligand therapy sector is undergoing rapid consolidation and capacity expansion, following the pattern set by the 2023 expansion of Novartis Pluvicto manufacturing in New Jersey. Recent activity, including the $1.65 billion Telix buyout, underscores the intense competition for isotope production scale.

Operators in the oncology space should monitor patient referral wait times, as current demand continues to exceed the capacity of specialized treatment centers. Providers should assess whether existing infrastructure can handle the increased volume of radioligand therapy administrations.

The takeaway

The race to scale radioligand therapy is as much a logistical operation as it is a clinical one. Leaders in this space should track the isotope supply chain as a primary metric for determining facility throughput and potential patient access.

Further reading

For more on the regulatory and supply chain dynamics of new treatments, visit the Healthcare section.

Source note: This article includes information reported by Pharma.

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Do you believe access to specialized radioligand therapies is improving for patients in your area?