Difference between revisions of "Enfortumab vedotin (Padcev)"
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==General information== | ==General information== | ||
| − | Class/mechanism from the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-nectin-4-antibody-drug-conjugate-asg-22ce NCI Drug Dictionary]: An antibody drug conjugate (ADC) containing a human monoclonal antibody AGS-22 targeting the cell adhesion molecule nectin-4 and conjugated to the cytotoxic agent monomethyl auristatin E (MMAE), via a proprietary enzyme-cleavable linker (AGS-22CE), with potential antineoplastic activity. The monoclonal antibody moiety of AGS-22CE selectively binds to nectin-4. After internalization and proteolytic cleavage, MMAE binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and induces apoptosis in nectin-4 overexpressing tumor cells. <ref name="insert">[https://astellas.us/docs/PADCEV_label.pdf Enfortumab vedotin (Padcev) package insert]</ref><ref>[[File:Enfortumabvedotin.pdf | Enfortumab vedotin (Padcev) package insert (locally hosted backup)]]</ref><ref>[https://www.padcev.com/ Padcev manufacturer's website]</ref> | + | Class/mechanism from the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-nectin-4-antibody-drug-conjugate-asg-22ce NCI Drug Dictionary]: An antibody drug conjugate (ADC) containing a human monoclonal antibody AGS-22 targeting the cell adhesion molecule nectin-4 and conjugated to the cytotoxic agent monomethyl auristatin E (MMAE), via a proprietary enzyme-cleavable linker (AGS-22CE), with potential antineoplastic activity. The monoclonal antibody moiety of AGS-22CE selectively binds to nectin-4. After internalization and proteolytic cleavage, MMAE binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and induces apoptosis in nectin-4 overexpressing tumor cells. <ref name="insert">[https://astellas.us/docs/PADCEV_label.pdf Enfortumab vedotin (Padcev) package insert]</ref><ref>[[:File:Enfortumabvedotin.pdf | Enfortumab vedotin (Padcev) package insert (locally hosted backup)]]</ref><ref>[https://www.padcev.com/ Padcev manufacturer's website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <br>Extravasation: no information | ||
Revision as of 03:17, 20 September 2021
General information
Class/mechanism from the NCI Drug Dictionary: An antibody drug conjugate (ADC) containing a human monoclonal antibody AGS-22 targeting the cell adhesion molecule nectin-4 and conjugated to the cytotoxic agent monomethyl auristatin E (MMAE), via a proprietary enzyme-cleavable linker (AGS-22CE), with potential antineoplastic activity. The monoclonal antibody moiety of AGS-22CE selectively binds to nectin-4. After internalization and proteolytic cleavage, MMAE binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and induces apoptosis in nectin-4 overexpressing tumor cells. [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, Medscape, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Enfortumab vedotin (Padcev) package insert[1]
- Enfortumab vedotin (Padcev) patient drug information (Chemocare)[4]
- Enfortumab vedotin (Padcev) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 12/18/2019: Granted accelerated approval for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. (Based on EV-201)
- 7/9/2021: Regular approval for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy. (Based on EV-301)
- 7/9/2021: Regular approval for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. (Based on EV-301)
Also known as
- Code name: ASG-22CE
- Generic name: enfortumab vedotin-ejfv
- Brand name: Padcev