Difference between revisions of "Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)"
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| − | == | + | ==General information== |
| − | + | Class/mechanism: Radioligand therapeutic agent. The radionucleotide lutetium-177 is linked to vipivotide tetraxetan, which binds to PSMA (prostate-specific membrane antigen), a transmembrane protein that is expressed in prostate cancer. Binding of lutetium Lu 177 vipivotide tetraxetan to PSMA-positive cells results in delivery of beta-minus radiation, resulting in DNA damage and cell death. Lutetium 177's half-life is 6.647 days.<ref name="insert">[https://www.novartis.us/sites/www.novartis.us/files/pluvicto.pdf Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) package insert]</ref><ref>[[:File:Lutetium Lu 177 vipivotide tetraxetan.pdf | Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) package insert (locally hosted backup)]]</ref><ref>[https://www.us.pluvicto.com/ Pluvicto manufacturer's website]</ref> | |
| + | <br>Route: IV | ||
| + | <br>Extravasation: no information | ||
| + | |||
| + | For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> | ||
| + | |||
| + | ==Diseases for which it is established== | ||
| + | *[[Prostate cancer]] | ||
| + | |||
| + | ==Patient drug information== | ||
| + | *[https://www.novartis.us/sites/www.novartis.us/files/pluvicto.pdf Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) package insert]<ref name="insert"></ref> | ||
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | *2022-03-23: [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pluvicto-metastatic-castration-resistant-prostate-cancer FDA approved] 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. ''(Based on VISION<sub>PrCA</sub>)'' | ||
| + | |||
| + | ==History of changes in EMA indication== | ||
| + | *2022-12-09: Initial authorization in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant [[prostate cancer]] (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy. | ||
| + | |||
| + | ==Also known as== | ||
| + | *'''Generic names:''' Lutetium-177-PSMA-617, Lutetium PSMA | ||
| + | *'''Brand name:''' Pluvicto | ||
| + | |||
| + | ==References== | ||
| + | <references/> | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | + | [[Category:Beta emitters]] | |
[[Category:Radioconjugate]] | [[Category:Radioconjugate]] | ||
[[Category:Prostate cancer medications]] | [[Category:Prostate cancer medications]] | ||
| − | [[Category: | + | [[Category:EMA approved in 2022]] |
| + | [[Category:FDA approved in 2022]] | ||
Revision as of 16:22, 1 January 2024
General information
Class/mechanism: Radioligand therapeutic agent. The radionucleotide lutetium-177 is linked to vipivotide tetraxetan, which binds to PSMA (prostate-specific membrane antigen), a transmembrane protein that is expressed in prostate cancer. Binding of lutetium Lu 177 vipivotide tetraxetan to PSMA-positive cells results in delivery of beta-minus radiation, resulting in DNA damage and cell death. Lutetium 177's half-life is 6.647 days.[1][2][3]
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is established
Patient drug information
History of changes in FDA indication
- 2022-03-23: FDA approved 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. (Based on VISIONPrCA)
History of changes in EMA indication
- 2022-12-09: Initial authorization in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy.
Also known as
- Generic names: Lutetium-177-PSMA-617, Lutetium PSMA
- Brand name: Pluvicto