News|Videos|November 18, 2025

Nuclear Waste to Medicine: The UK’s Lead-212 Strategy for Cancer Care

To meet rising demand, developers of precision radiopharmaceutical therapies must overcome challenges in global isotope supply and align R&D platforms with evolving FDA guidance on clinical dosimetry.

The United Kingdom National Nuclear Laboratory (UKNNL) and Medicines Discovery Catapult (MDC) are co-leading a major project to utilize recycled nuclear materials for the development of next-generation cancer treatments (1). This effort, backed by £18.8 million (US$24.7 million) in combined public and industry funding, focuses on harvesting a radionuclide known as lead-212, from used nuclear fuel, to create treatments called Targeted Alpha Therapies (1).

According to a press release from UKNNL, lead-212 is an untapped asset in the UK that showcases the ability of radiopharmaceuticals to uniquely combine targeted diagnosis and therapy (1–3). However, the industry faces significant challenges related to escalating global demand, stringent regulatory requirements, and highly vulnerable supply chains stemming from reliance on imports and the short half-life of radioisotopes (2,3).

As pharmaceutical companies invest in this rapidly advancing field, overcoming development, regulatory, and manufacturing complexities is essential to accelerating these treatments to market (2,3). The following findings summarize the critical implications for industry professionals.

How is manufacturing sustainability and supply changing?

The development of a sustainable lead-212 supply from recycled nuclear fuel helps address the global reliance on imports and limited capacity for key radionuclides (1,4). Industry efforts, including the development of generator technologies and enhanced domestic production capabilities, aim to ensure a reliable source and harmonize complex logistics for these short-shelf-life medicines (5).

What new R&D platforms are needed?

Drug developers must leverage integrated platforms that combine expertise in radiochemistry, imaging technologies, and preclinical oncology models to generate high-quality translational data and de-risk investment (2,3,6). Researchers are also focused on advancing radio drug conjugates by optimizing the chemistry required to link radio ligands to targeting molecules, drawing on lessons learned from antibody-drug conjugates (5,7).

How will regulatory scrutiny evolve?

Recent FDA draft guidance emphasizes the need for sponsors to identify optimized dosages for systemic radiopharmaceutical therapies by providing a better understanding of pharmacodynamics, therapeutic window, and dosimetry (5,7). Clinical trials must include safeguards like appropriate participant selection and safety monitoring, and may study dosages exceeding historical external beam radiation therapy organ tolerances if scientifically justified.

References

1. UKNNL. UK Nuclear Revolution Powers Next-Generation Precision Cancer Therapies. Press Release. Nov. 18, 2025.
2. Haigney, S. Advancing Radiopharmaceutical Development.PharmTech.com, Oct. 2, 2025.
3. Haigney, S. Collaborating on the Development of Radiopharmaceuticals.PharmTech.com, Oct. 6, 2025.
4. Barton, C. EMA Is Tackling Vulnerabilities in the Supply Chain of Radiopharmaceuticals.PharmTech.com, June 4, 2025.
5. Haigney, S. Why Radiopharmaceuticals Are Ideal for Treating Cancer. BioPharm International®/ Pharmaceutical Technology®/ Pharmaceutical Technology® Europe Trends in Formulation eBook 2025 October.
6. MDC and Crown Bioscience. Medicines Discovery Catapult and Crown Bioscience Form Strategic Global Alliance for Radiopharmaceutical Innovation. Press Release. Sept. 11, 2025.
7. FDA. Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development. Draft Guidance for Industry (OCE, CDER, August 2025).

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.