Radiopharmaceutical roadmap: iodine → lutetium → actinium

Overview

1. 1946-2000historic

   Radioiodine and early radioimmunotherapy

   131I cures differentiated thyroid cancer, the first theranostic. Strontium-89 and samarium-153 palliate bone pain. 90Y-ibritumomab and 131I-tositumomab (2002-03) work in lymphoma but fail commercially.

   Hide era· 1 record

   Thyroid cancer
2. 2013-2018historic

   Radium-223 and Lutathera

   Radium-223 (ALSYMPCA, 2013) is the first alpha emitter approved, for bone metastases. 177Lu-DOTATATE (NETTER-1, 2018) establishes the modern peptide receptor radionuclide therapy paradigm with a matched 68Ga-DOTATATE PET.

   Show era· 2 records
3. 2020-2022current

   PSMA theranostics

   PSMA PET approved (68Ga-PSMA-11 2020, Pylarify 2021); Pluvicto approved (VISION, 2022). Novartis builds the first radioligand commercial franchise; supply and site-capacity constraints appear.

   Show era· 4 records
4. 2023-2026current

   Earlier lines, consolidation, and an M&A wave

   PSMAfore moves Pluvicto pre-chemotherapy (2025), NETTER-2 moves Lutathera to first line (2024); 2026 label expansions. BMS buys RayzeBio ($4.1B), AstraZeneca buys Fusion ($2.4B), Lilly buys Point; Bayer, Sanofi, Novartis expand. Pylarify TruVu approved March 2026. ITM-11 reads out a positive phase 3.

   Hide era· 5 records

   PSMAfore⟳Actinium-225 DOTATATEFusion Pharmaceuticals (AstraZeneca)RayzeBio (BMS)ITM Isotope Technologies Munich

   Trial outcomes

   PSMAfore

   In plain words

   What these results mean for people, not percentages

   469 enrolled

   Radiographic progression-free survivalprimarysurrogate endpoint

   • Median 12 vs 5.6 months with 177Lu-PSMA-617 compared with ARPI switch; about 6.4 months longer for half the group.
   • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
   • Put another way, the treated group had about 59 percent lower chance of the event at any given time (hazard ratio 0.41, likely range 0.29 to 0.56).

   Overall survival (crossover-adjusted)survival endpoint

   • The treated group had about 41 percent lower chance of the event at any given time (hazard ratio 0.59).
   • The absolute difference, how many more people out of 100 were helped, is not reported here.
   • Unadjusted OS HR 0.98 with 84% crossover from control

   Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

   Pictograms, table and sources on the trial page

5. 2026-2029emerging

   Alpha emitters and new targets

   225Ac-PSMA (Novartis, Bayer Trillium, Fusion FPI-2265), 225Ac-DOTATATE (RYZ101) and 212Pb-DOTAMTATE are in phase 3; FAP radioligands (FAP-2286) are in phase 2; GRPR, CAIX, B7-H3, DLL3 radioconjugates are in early trials. TerraPower's Philadelphia Ac-225 plant aims for a 20-fold supply increase. Dosimetry-guided dosing enters trials.

   Show era· 6 records
6. 2029+speculative40% to 65%likely

   Speculative: radioligands as a standard modality

   Alpha therapy in hormone-sensitive prostate cancer and after ADC failure; pan-cancer FAP theranostics; radio-ADCs and pretargeting; combination with PARP inhibitors, IO, and ADCs; automated decentralised radiopharmacies; total-body PET for ultra-low-dose dosimetry.

   Show era· 3 records

Every era's records, trial outcomes and papers, and every watch item, as JSON.