Advancing radiopharmaceutical development: Integrated clinical trial expertise mitigates risk

Precision oncology radiopharmaceuticals (RPTs) use ligands to target specific proteins on cancer cells and deliver a lethal radioactive payload. First-generation products had limited commercial uptake due to high costs, misaligned oncology referral incentives, complex manufacturing, and the fact that many non-academic oncologists were unfamiliar with the treatments. ^1,2   However, RPTs are undergoing a renaissance with the development of second-generation products, especially those with a diagnostic component, called theranostics. Theranostics first diagnose and stratify patients with a radiolabelled agent that enables accurate 3D imaging of the tumor. Then, they deliver a personalized therapeutic dose of the same or a complementary radionuclide that kills cancer cells, resulting in better therapeutic outcomes with fewer off-target side effects for patients.³ 

The recent surge in RPT development is fueled by multiple factors, including:

Clinical and commercial success. Novartis’s two RPT theranostics—Lutathera for neuroendocrine tumors (approved in 2018) and Pluvicto for prostate cancer (approved in 2022, label expanded in 2025) generated more than $2 billion in net sales in 2024.⁴ 

Advances in isotope production. Better commercial nuclear reactors, cyclotron technology, and laser-based isotope separation have improved supply chain reliability and produced novel isotopes such as alpha-emitting radionuclides.⁵

Regulatory expedited programs. 2024 saw a flood of FDA Fast Track designations for sponsors of investigational RPTs, including Clarity Pharmaceuticals, Perspective Therapeutics, Telix, Abdera Therapeutics, Full-Life Technologies, and Oncoinvent.⁶  

Multi-target potential. RPTs offer multi-target flexibility—including the choice of isotope, ligand, target, and conjugation—and synergies with existing oncology portfolios, which investors now prefer over precision medicines that target tiny subpopulations of patients.⁷ 

Discovery of new targets and antibodies. Recent advances in mass spectrometry and computational proteomics are accelerating the discovery of new cancer antigens, which can be targeted using the high specificity and affinity of novel antibodies and antibody derivatives.