FDA Approves Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for PSMA-positive metastatic castration-resistant prostate cancer.

Not reported in label.

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. Patients must be selected for treatment using LOCAMETZ or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors.

The recommended PLUVICTO dosage is 7.4 GBq (200 mCi) intravenously every 6 weeks for 6 doses, or until disease progression, or unacceptable toxicity. It is a radiopharmaceutical and must be handled with appropriate safety measures, including waterproof gloves and effective radiation shielding, by qualified healthcare providers. Dose interruption, reduction by 20% to 5.9 GBq (160 mCi) once, or permanent discontinuation may be required due to adverse reactions such as myelosuppression, renal toxicity, dry mouth, gastrointestinal toxicity, fatigue, or electrolyte abnormalities. If a treatment delay due to an adverse reaction persists for > 4 weeks, permanent discontinuation should be considered.

Trial data not available in label.

Not reported in label.

PLUVICTO is a radioligand therapeutic agent indicated for adult patients with PSMA-positive mCRPC after ARPI therapy, either before or after taxane-based chemotherapy.