Lutetium (177Lu) vipivotide tetraxetan

Lutetium (177Lu) vipivotide tetraxetan (Pluvicto, Novartis Europharm Limited) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: PSMA (1).
Approved indications of Lutetium (177Lu) vipivotide tetraxetan
Biomarker requirementRegimenSettingConditions
Prostate cancer1
PSMA-positive
+ 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
Full text of section 4.1 (therapeutic indications)

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).

Label history

13 changes to the Pluvicto label since 2024, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes