Proposed US nuclear safety rules could create barriers to Pluvicto patient access

The US Nuclear Regulatory Commission has proposed new guidance on the release of patients treated with radioactive materials that could create additional compliance hurdles for radioligand therapies such as Novartis’ Pluvicto. Under the draft methodology, a full six-dose course of Pluvicto would exceed the proposed release threshold, potentially requiring longer hospital stays or patient-specific radiation calculations. Industry and medical groups have raised concerns that the changes could particularly affect community treatment centres and limit access to the therapy.