PSMA in prostate cancer

1 EU-approved indication in prostate cancer needs a PSMA result: lutetium (177Lu) vipivotide tetraxetan (3rd line+, metastatic).

Castration status

Approved indications, Prostate cancer
DrugBiomarker requirementRegimenSettingConditions
PSMA-positive1
+ androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition
3L+
metastatic
Castration-resistant only; After AR pathway inhibition and taxane-based chemotherapy; Progressive disease

24 approvals for Prostate need no biomarker and apply whatever the result. All approvals for Prostate

See also

Label wording1

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Lutetium (177Lu) vipivotide tetraxetan (Pluvicto)
    Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane-based chemotherapy (see section 5.1).