lutetium Lu 177 vipivotide tetraxetan

FDA Drug Profile — PLUVICTO

Drug Details

Generic Name
lutetium Lu 177 vipivotide tetraxetan
Brand Names
PLUVICTO
Application Number
NDA215833
Sponsor
Novartis Pharmaceuticals Corporation
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

Indications and Usage

1 INDICATIONS AND USAGE PLUVICTO is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy. PLUVICTO is a radioligand therapeutic agent indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy. ( 1 )