Radiopharmaceutical therapy: From bench to bedside

Radiopharmaceutical Therapy (RPT) is an evolving and pioneering therapeutic modality in cancer treatment, offering significant promise for improving patient outcomes. In RPT, radiopharmaceuticals are administered either systemically or locally, delivering radiation to tumor cells or adjacent tissues. The outcome is targeted cell death and tumor shrinkage, thereby enhancing treatment efficacy while reducing side effects commonly compared to traditional therapies, such as chemotherapy, hormone therapy, and radiation therapy. RPT development involves a lengthy process that must pass successfully through rigorous preclinical studies, well-structured clinical trials, and thorough post-approval monitoring. All are aimed at ensuring both safety and effectiveness in clinical practice. Innovations in RPT will be driven by collaborative efforts of pharmaceutical companies, academic institutions, healthcare providers, and regulatory bodies. Such interdisciplinary partnerships are crucial to realizing the full potential of RPT as a transformative cancer therapy. This review provides a comprehensive overview of the entire process of radiopharmaceutical development, from preclinical investigation to clinical application, including development history, classifications of radiopharmaceuticals, preclinical research considerations, intricacies of FDA approval processes, regulatory pathways, and marketing strategies. This up-to-date tutorial of RPT intends to guide and inspire future research directions, ultimately advancing the field and improving therapeutic outcomes for patients with cancer. This review provides a comprehensive overview of the entire radiopharmaceutical development process, spanning from preclinical research to clinical application. It focuses primarily on key stages, including research considerations, clinical translation, clinical trials, and regulatory pathways. Within each section, various aspects of these stages are discussed to clarify the critical elements involved.