Curium Won FDA Approval for Bexlutry Therapy

The company secured approval in September 2026 to expand its radioligand therapy presence in the United States.

Updated on Sept. 29, 2026 in Healthcare

Bold flat-color editorial illustration of a cylindrical medical transport canister, representing the specialized supply chain for radioligand therapy. — Curium secured FDA approval in September 2026 for its radioligand therapy Bexlutry, expanding the company's presence in the targeted radioactive treatment market. AI Illustration. Upload story photo >

Live Poll

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

Curium received FDA approval for its radioligand therapy, Bexlutry, in September 2026. This move positions the firm to compete in a rapidly growing market for targeted radioactive treatments.

Why it matters

Control over supply chains for isotopes is critical as manufacturers work to address the two- to six-week wait times currently facing patients seeking these therapies. Scaling production capacity allows companies to manage the strict logistical demands of isotopes like lutetium-177, which has a half-life of only 6.7 days.

Novartis-branded Lutathera and Pluvicto generated $1.7 billion in sales during the first half of 2026. Meanwhile, Curium has set a goal to provide isotope supplies to 100,000 patients globally within the next five years.

The players

Curium

Formed from a 2017 merger of IBA Molecular and Mallinckrodt Nuclear Medicine, this company specializes in radiopharmaceuticals.

Novartis

This multinational pharmaceutical corporation maintains a large portfolio of radioligand therapies, including Pluvicto and Lutathera.

FDA

The federal agency is responsible for overseeing the safety and efficacy of medical devices and pharmaceutical products in the United States.

The details

Curium leverages a complex logistics network including commercial and charter aircraft to transport time-sensitive isotopes from international production sites in the Netherlands and France. Sites delivering these treatments must maintain specialized infrastructure for radiation protection and provide medical teams trained in handling radioactive materials.

Curium was established through a merger in 2017.
Novartis expanded production capacity in New Jersey in 2023.
Curium secured access to lutetium-177 production in 2024.
Lutathera and Pluvicto sales totaled $1.7 billion in the first half of 2026.
The FDA granted approval for Bexlutry in September 2026.

Market Landscape

Curium's entry follows the pattern established by the 2023 expansion of Novartis Pluvicto manufacturing lines in New Jersey to capture more market share. This shift signals a broader move toward vertical integration as firms attempt to consolidate their influence in the high-stakes radioligand sector.

Patients may see potential relief in wait times as increased production capacity aims to resolve existing bottlenecks in treatment access. Individuals seeking these therapies should consult their medical providers regarding facility availability and potential scheduling changes.

The takeaway

The growth of radioligand therapy highlights the critical importance of supply chain resilience when working with short-lived isotopes. Success in this field requires balancing high-tech medical production with the precise logistical coordination needed for patient delivery.