The U.S. Food and Drug Administration (FDA) has approved a new treatment called Pluvicto for a specific type of advanced prostate cancer. It is for adult men with prostate cancer that has spread and has stopped responding to standard hormone treatments. This type of cancer is called metastatic castration-resistant prostate cancer. Pluvicto is a targeted radiation therapy that seeks out and delivers radiation directly to cancer cells that have a specific marker called PSMA. This approval is significant because it offers a new option for patients who have already tried other major treatments, including certain hormone therapies or chemotherapy. It represents another tool doctors can use in managing this serious disease. An important part of this approval is that patients must first have a special imaging scan to confirm their tumors have the PSMA marker. This ensures the treatment is given to those most likely to benefit. The treatment is given as an intravenous infusion every six weeks, for up to six doses. As with any new treatment, it's important to remember that this is an option for a specific group of patients. The most important step for anyone interested in this news is to have a calm and open conversation with their own doctor. A healthcare team can provide personalized information about whether this treatment might be relevant based on an individual's unique medical history and current health.
FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for PSMA-positive metastatic castration-resistant prostate cancerFDA approved a new treatment for advanced prostate cancer called Pluvicto
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The FDA has approved the radioligand therapeutic agent Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). The indication is for patients who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy, or who have received prior taxane-based chemotherapy. This approval provides a new therapeutic option for a defined subset of patients with advanced prostate cancer. Patient selection requires confirmation of PSMA expression in tumors using an approved PSMA PET product, such as LOCAMETZ. The recommended dosage is 7.4 GBq (200 mCi) administered intravenously every 6 weeks for up to 6 doses, with provisions for dose modification or discontinuation based on adverse reactions.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
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.
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