Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 1000 MBq/mL [27 mCi/mL] in a single-dose vial) |
Drug Class | Radioligand therapeutic agents |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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 (AR) pathway inhibition and taxane-based chemotherapy.
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Summary
- Pluvicto (lutetium 177Lu vipivotide tetraxetan) 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 (AR) pathway inhibition and taxane-based chemotherapy.
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Lutetium-177 (Lu-177) - PSMA-617 has shown effectiveness in treating metastatic castrate-resistant prostate cancer (mCRPC) that is unresponsive to traditional hormonal and novel anti-androgen therapies, supported by findings from real-world prospective and phase III clinical trials.
- The study does not provide direct comparative effectiveness data between Lu-177 and other mCRPC treatments; however, it suggests Lu-177 as a potential frontline option after the failure of other therapies.
- No specific differences in effectiveness among population subgroups are reported, though the study indicates a need for biomarkers to identify patients who may benefit most from Lu-177 treatment.
- The study indicates that Lutetium-177 (Lu-177) - PSMA-617 is tolerable, suggesting a manageable safety profile, but no specific safety outcomes, adverse effects, or comparative safety data are provided. There are no significant safety concerns or adverse effects mentioned for specific populations or subgroups.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Prescribing Information. | 2022 | Advanced Accelerator Applications USA, Inc., Millburn, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Lutetium-177 PSMA for the treatment of metastatic castrate resistant prostate cancer: A systematic review. | 2023 | Expert review of anticancer therapy |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Clinical Best Practices for Radiation Safety During Lutetium-177 Therapy. | 2023 | Health Physics |