177Lu-PSMA (R)Evolution in Cancer Care: Is It Really Happening?

Abstract

Radiopharmaceutical therapy (RPT) is established as an innovative, effective, and well-tolerated treatment platform approved for well-differentiated neuroendocrine tumors and advanced prostate cancer (PC) and is being investigated in many other cancers such as breast, lung, and thyroid (1–3), emerging as an essential pillar in oncology. On the basis of several seminal clinical studies, [177Lu]Lu-prostate-specific membrane antigen-617 (hereafter referred to as 177Lu-PSMA-617) is now integrated into international clinical guidelines for PC and is gaining significant traction among patients and physicians alike because of its proven efficacy, favorable safety profile, and ability to maintain quality of life longer than other therapies, for example, chemotherapy (3–5). Efforts to expand capacities for manufacturing 177Lu-PSMA-617 have successfully addressed post-approval supply shortages encountered in the United States and Europe, leading to the projected availability of 250,000 RPT doses in 2024 (6). Although this shows that RPT can be produced at industrial scale to meet increasing demand, the readiness of health care systems (HCSs)—in other words, the availability of health care professionals, policies, processes, infrastructure, and resources to deliver RPT in a timely and equitable manner—remains highly variable. With a projected exponential growth in RPT (7,8) as many pharmaceutical companies invest in theranostics, now is the right time to ask: Is a 177Lu-PSMA (r)evolution in cancer care really happening? In this article, we explore the opportunities and challenges in integrating RPT into everyday clinical practice and the changes needed by HCSs to establish this therapy as an essential pillar in oncology care.