
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
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
What new R&D platforms are needed?
Drug developers must
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Recent FDA draft guidance emphasizes the need for sponsors to identify optimized dosages for systemic radiopharmaceutical therapies by providing a better understanding of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.
2. Haigney, S.
3. Haigney, S.
4. Barton, C.
5. Haigney, S.
6. MDC and Crown Bioscience.
7. FDA.
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