Radiopharmaceuticals play a niche role in treating cancer, despite having labels in multiple oncology indications in the US and EU, with few agents being commercially successful. In March, Novartis announced that its anti-PSMA radioligand molecule 177Lu-PSMA-617 (AAA-617) met its primary endpoints in progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), with plans to file imminently for regulatory application with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). This outcome in a large oncology indication is likely to encourage further innovation in radiopharmaceuticals.

The third-phase VISION study showed an improvement in overall survival (OS) and radiographic progression-free survival (rPFS) after the administration of AAA-617 compared with treatment with the best available supportive care or standard of care. Detailed data are not available yet, but the high level of unmet need in this patient population (third-line patients, after hormone therapy and at least one taxane regimen) suggests that any improvement over the best available option will lead to high uptake of AAA-617 in mCRPC clinical practice.

Oncology indications with marketed radiopharmaceuticals in the US and EU include neuroendocrine tumours (NETs), non-Hodgkin’s lymphoma, thyroid cancer and bone metastases originating from prostate cancer. So far, Novartis’ Lutathera, with a label in NETs, has been the most commercially successful, with sales of $441m in 2019, followed by Bayer ’s Xofigo with a label for bone metastases, which recorded sales of $339m in 2019. The current radiopharmaceuticals oncology pipeline includes five agents in the third phase, 28 agents in the second phase and 24 agents in the first phase. The late-stage pipeline for radiopharmaceuticals in oncology is presented in the table below.

Approval from the FDA and EMA would give Novartis first-to-market advantage for the radiopharmaceutical segment in the third line of therapy in mCRPC, placing it ahead of Point Biopharma ’s competing late-stage product PNT2002, and generating lucrative sales that could even go into blockbuster territory. GlobalData’s consensus analyst forecast database places AAA-617 at $753m total sales by 2026, with the total market value of radiopharmaceuticals in oncology projected to increase from $738m last year to $3.6bn by 2026. It is therefore expected that the radiopharmaceuticals market in oncology will continue to attract research and development (R&D) investment and become a more common cancer treatment.