FDA approves Pluvicto in metastatic hormone-sensitive prostate cancer

Radioligand therapy just crossed a threshold worth paying attention to.

The FDA has approved Novartis’ Pluvicto for use earlier in prostate cancer treatment — specifically in PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), not just the castration-resistant stage it was originally approved for.

Why this matters:

→ It roughly doubles the number of patients eligible for the drug
→ Over 80% of prostate cancer patients present with the PSMA biomarker Pluvicto targets
→ In the PSMAddition trial, adding Pluvicto to standard care cut the risk of progression or death by up to 33%
→ Pluvicto can now be used across every stage of PSMA-positive metastatic prostate cancer

The bigger story here isn’t just one drug — it’s radioligand therapy proving itself as a legitimate, scalable class of cancer treatment. Pluvicto pairs a targeting ligand with a radioactive isotope (lutetium-177) that delivers radiation directly to cancer cells, sparing healthy tissue in a way conventional radiotherapy can’t.

Precision oncology is moving earlier in the treatment journey — not just treating cancer that’s already resistant to everything else, but intercepting it sooner. That shift changes outcomes.

The Study: Based on the Phase III PSMAddition trial, which tested the drug in 1,144 patients.
@Karthasis