Lutetium Lu-177 vipivotide tetraxetan
Is Lutetium Lu-177 vipivotide tetraxetan legal in the US?
Yes, FDA approved for advanced prostate cancer that has spread and carries a marker called PSMA.
Approved. Lutetium Lu-177 vipivotide tetraxetan (Pluvicto, Novartis) was approved in March 2022 for PSMA-positive metastatic castration-resistant prostate cancer after androgen receptor pathway inhibition and taxane chemotherapy, extended in March 2025 to patients who have not had chemotherapy, and extended again in mid-2026 to PSMA-positive metastatic hormone-sensitive prostate cancer in combination with an androgen receptor pathway inhibitor and androgen deprivation therapy. 23
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Citations
- Sartor 2021, NEJM: Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer (VISION) doi.org
- Novartis: Pluvicto US prescribing information novartis.com
- FDA 2026: Pluvicto prescribing information, expanded indication accessdata.fda.gov
Reference information only, not medical advice. Drawn from the Lutetium Lu-177 vipivotide tetraxetan article, fact-checked against the cited sources. No dosing anywhere on this site.