Drug updated on 4/18/2024
| 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.
Summary
- Lutetium 177Lu vipivotide tetraxetan (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 inhibition and taxane-based chemotherapy.
- A single systematic review/meta-analysis was reviewed to gather information about the application, effectiveness, and comparative status of this drug within this challenging oncologic context.
- The study highlights that mCRPC represents a particularly aggressive stage of prostate cancer resistant to standard hormonal therapies. In such cases, Pluvicto emerges as a promising alternative therapeutic strategy after failure of novel anti-androgen therapy and chemotherapy.
- Regarding efficacy and safety, lutetium 177Lu vipivotide tetraxetan has transitioned from real-world prospective trials to inclusion in phase III clinical trials. This progression indicates its increasing adoption due to robust evidence supporting its use; tolerability is highlighted as one notable feature.
- Although there is no direct comparison data between Pluvicto and other drugs regarding safety or effectiveness available, the study positions Pluvicto as a "new frontline treatment option" post-failure of conventional therapies which suggests its significance in effectively treating mCRPC while maintaining patient safety standards deemed sufficient by regulatory agencies.
- Future directions emphasize identifying biomarkers for optimizing patient selection for lutetium 177Lu vipivotide tetraxetan therapy - an approach towards personalized medicine where treatments can be tailored based on individual patient characteristics, including subgroup considerations. There is anticipation that radioligand treatments like lutetium 177Lu vipivotide tetraxetan will be employed earlier in the treatment continuum, potentially enhancing outcomes further.
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 |