Miljöpåverkan
Lutetium(Lu-177)vipivotid tetraxetan
Miljörisk:
Användning av lutetium(lu-177)vipivotid tetraxetan har bedömts medföra försumbar risk för miljöpåverkan.
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Detaljerad miljöinformation
PluvictoTM (lutetium (177Lu) vipivotide tetraxetan), a novel targeted radioligand therapy (RLT), is a prostate-specific membrane antigen (PSMA)-binding ligand bound to a DOTA chelator radiolabeled with lutetium-177. It is indicated in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition for the treatment of adult patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane-based chemotherapy. Upon the binding of Pluvicto to PSMA-expressing cancer cells, the beta-minus emission from lutetium-177 delivers therapeutic radiation to the targeted cell, as well as to surrounding cells, and induces DNA damage which can lead to cell death. Lutetium-177 decays to a stable hafnium-177 with a physical half-life of 6.647 days (Pluvicto SmPC, EMA 2022).
This drug product is administered to patients under controlled conditions at the appropriate hospital unit, by trained personnel, specialized in the administration of radiopharmaceuticals. Once Pluvicto is administered to the patient, any unused medicinal product or waste material is disposed of following local requirements. Pluvicto shows a bi-exponential elimination with a geometric mean terminal elimination half-life of 41.6 hours (Pluvicto SmPC EMA 2022). The concentration of 177Lu delivered to the environment is negligible and it is considered not to have significant impact on the environment, as compared to the natural background radiation.
The pharmacological activity of Pluvicto is exerted by the radionuclide. The rest of the molecule is composed of a protein, which is considered to result in insignificant environmental impact, and DOTA, which is a bifunctional chelator but does not have any pharmacological activity per se. Based on all the above, Pluvicto is considered to result in insignificant environmental impact.
References
• Pluvicto SmPC EMA 2022. Accessed on 30th May 2024. Available from: https://www.ema.europa.eu/en/documents/product-information/pluvicto-epar-product-information_en.pdf