Radiotheranostics: a roadmap for future development
A group of leading nuclear medicine specialists set out, in one article, what needs to happen - in science, manufacturing, regulation and training - for more radioactive scan-and-treat drugs to reach patients over the following five years.
Overview
This roadmap article, led by Ken Herrmann with co-authors including Jason Lewis, argues that radiotheranostics - radiopharmaceuticals that both image and treat the same molecular target - had reached an inflection point by 2020, with several agents already approved and many more in the pipeline. Rather than reporting new trial data, it lays out the practical barriers standing in the way of that pipeline reaching patients: logistics of a decaying drug (short shelf life, need for rapid distribution), isotope supply chains, the absence of harmonised regulatory frameworks for paired diagnostic-therapeutic products, reimbursement, and the shortage of trained nuclear medicine physicians and technologists.
The authors call for multidisciplinary clinical trial designs that pair imaging biomarker development with therapeutic dose-finding from the outset, rather than treating the diagnostic and therapeutic halves of a theranostic pair as separate regulatory programmes.
Published in the same year as the FDA approval of 177Lu-dotatate's expanded indications and shortly before the VISION trial results, it is frequently cited as a statement of the field's ambitions and obstacles just before radioligand therapy entered mainstream oncology practice with Pluvicto's 2022 approval.
- Identifies logistics of short-half-life radiopharmaceuticals, isotope supply, and fragmented regulatory pathways for paired diagnostic-therapeutic products as the main barriers to radiotheranostics reaching more patients.
- Calls for trial designs that integrate imaging-biomarker qualification with therapeutic dose-finding rather than developing the diagnostic and therapeutic halves separately.
- Flags workforce shortages in nuclear medicine training as a practical constraint on scaling radiotheranostics services.
This article is a call to action from senior nuclear medicine physicians: the treatments were becoming ready, but hospitals, regulators and isotope suppliers were not yet organised to deliver them at scale - a warning that proved accurate when demand for lutetium-177 PSMA therapy outstripped supply after 2022.
- An expert roadmap and opinion piece, not a systematic review or trial report; recommendations reflect the authors' priorities rather than a formal consensus process.
- Written before the VISION trial and Pluvicto's approval, so some of its forward-looking statements have since been superseded by events.
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