Towards a European production of stable isotopes for novel nuclear medicine therapies (SAMIRA/ERVI)

Expected Outcome: the project results are expected to contribute to the following outcomes: support for the development of EU production of stable isotopes that are essential for the manufacturing of radionuclides used in novel nuclear medicine therapies; strengthening of the resilience and security of the EU medical radioisotope supply chain by securing access to source materials, reducing dependence on third countries and enhancing industrial-scale production (including the sourcing of stable isotopes); leveraging of the knowledge and expertise of nuclear scientists, physicists and engineers in order to develop and optimise the processes for the EU-based production of stable isotopes, while contributing to Europe’s Beating Cancer Plan and implementing the Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA). Scope: radiological and nuclear technologies are integral to modern healthcare. They play a crucial role in cancer care – from early detection and diagnosis to treatment and palliative support. They also support the diagnosis and management of a wide range of other conditions (including cardiovascular and neurological diseases). Each year, patients throughout the EU benefit from the application of nuclear medicine in the diagnosis and treatment of cancer and other serious conditions. Innovations such as targeted radionuclide therapy (also known as radioligand therapy) are reshaping medicine by enabling more precise and personalised treatment. Medical radioisotopes are essential both for diagnostics and for an expanding array of therapeutic applications (particularly in oncology). The EU’s supply of innovative radiopharmaceuticals for cancer therapy faces growing risks due to uncertainties over the availability of rare stable isotopes that are imported from Russia. One key concern is the availability of precursor materials for medical radioisotope production (particularly Yb-176, which is essential for innovative medicines in the EU). The EU’s reliance on Russia for Yb-176 and other stable isotopes is a strategic vulnerability. Reducing dependence on foreign suppliers and diversifying the supply chain will enhance the EU’s resilience and security of supply. This action aims to mitigate supply risks by establishing the secure and sustainable production of stable isotopes. These include Yb-176, which is essential for Lu-177 manufacturing and is the main component of radiopharmaceuticals like Lutetium-177-PSMA (used to treat prostate cancer) and Lutetium-177 Dotatate (used in therapies against neuroendocrine tumours). The production of…