The FDA has expanded the indication for ¹⁷⁷Lu-PSMA-617 (Pluvicto®), now approving its use before chemotherapy in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

Eligible patients must have:

• PSMA PET-positive disease
• disease progression on androgen deprivation therapy (ADT) and one androgen receptor pathway inhibitor (ARPI)

The decision is based on positive results from the phase 3 PSMAfore trial (NCT04689828).