PMID-36469000 – FDA Approval Summary Lu-177-PSMA-617 Pluvicto
Keam SJ. FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer. Clin Cancer Res. 2023;29(9):1651-1657.
Quick Reference
| Property | Value |
|---|---|
| PMID | 36469000 |
| DOI | 10.1158/1078-0432.CCR-22-2875 |
| Year | 2023 |
| Journal | Clinical Cancer Research |
| Study Type | Narrative Review (FDA approval summary) |
| Evidence Level | V |
| Sample | N/A (regulatory review of VISION trial data) |
| Peptide(s) Studied | Lutetium-177-PSMA-617 |
Key Findings
- FDA granted traditional approval on March 23, 2022, for 177Lu-PSMA-617 (Pluvicto, lutetium Lu 177 vipivotide tetraxetan)
- Approved indication: adult patients with PSMA-positive mCRPC who have received AR pathway inhibition and taxane-based chemotherapy
- Companion diagnostic: 68Ga-PSMA-11 (Locametz) for PSMA-positive patient selection
- Recommended dose: 7.4 GBq (200 mCi) IV every 6 weeks for up to 6 cycles
- FDA review confirmed OS benefit (HR 0.62) and PFS benefit (HR 0.40) from the VISION trial
- Key safety concerns highlighted: myelosuppression, renal toxicity, secondary malignancies (MDS/AML risk ~2%), dry mouth
- REMS (Risk Evaluation and Mitigation Strategy) not required, but treatment restricted to authorized facilities
Study Design
FDA approval summary reviewing the regulatory basis for approval, including efficacy and safety data from the VISION trial (NCT03511664), manufacturing considerations, and post-marketing requirements.
Limitations
- Approval limited to post-AR inhibitor and post-taxane setting (late-line)
- Requires PSMA-PET imaging for patient selection, which may not be universally accessible
- Long-term safety data (particularly secondary malignancies) still accumulating
- Supply chain challenges for radiopharmaceutical manufacturing were noted
Clinical Relevance
This FDA approval summary documents the regulatory basis for the first PSMA-targeted radioligand therapy approved for prostate cancer. It marked the first approval of 177Lu-based therapy for any solid tumor (following the earlier 177Lu-DOTATATE approval for NETs in 2018). The approval has transformed the treatment landscape for advanced prostate cancer, adding a new therapeutic modality beyond hormonal therapy, chemotherapy, and immunotherapy.
Related
- Lutetium-177-PSMA-617
- Lutetium-177-DOTATATE
- Cancer Adjunct Therapy
- PMID-34161051 – VISION Trial Lu-177-PSMA-617 in mCRPC
#research #narrative-review #lutetium-177-PSMA-617 #evidence-level-V