Enfortumab Vedotin

Review

Enfortumab Vedotin

No authors listed

In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.

2023 Nov 30.

PMID: 38154012
Bookshelf ID: NBK598876

Free Books & Documents

Review

Enfortumab Vedotin

No authors listed.

Free Books & Documents

In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.

2023 Nov 30.

PMID: 38154012
Bookshelf ID: NBK598876

Excerpt

Enfortumab vedotin is a human monoclonal antibody conjugate that is used in the therapy of refractory, locally advanced or metastatic urothelial cancer. Enfortumab vedotin has been linked to transient, mild-to-moderate serum enzyme elevations during therapy but has not been implicated in instances of clinically apparent liver injury with jaundice.

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1. Wellstein A, Giaccone G, Atkins MB, Sausville EA. Pathway targeted therapies: monoclonal antibodies, protein kinase inhibitors, and various small molecules. In, Brunton LL Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1203-36.(Textbook of pharmacology and therapeutics).
1. FDA. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761137Orig1s000M...(FDA website with product labels and initial multidiscipline review of enfortumab vedotin mentions that in the total safety cohort of 310 patients, ALT elevations occurred in 34% of patients and were above 5 times ULN in 3%, led to dose interruption in 2%, and discontinuation in 1% but there were no cases of clinically apparent liver injury with jaundice attributed to therapy).
1. Rosenberg JE, O'Donnell PH, Balar AV, McGregor BA, Heath EI, Yu EY, Galsky MD, et al. Pivotal trial of enfortumab vedotin in urothelial carcinoma after platinum and anti-programmed death 1/programmed death ligand 1 therapy. J Clin Oncol. 2019;37:2592-2600.(Among 125 patients with refractory or relapsed, locally advanced or metastatic urothelial cancer treated with enfortumab vedotin, the objective response rate was 44%, while adverse events occurred in most patients including fatigue in 50%, alopecia 49%, decreased appetite 44%, dysgeusia 40%, and peripheral neuropathy 40%, leading to dose reductions in 32% and discontinuation in 12%; ALT elevations arose in 20% that were above 5 times ULN in 2). - PMC - PubMed
1. Joubert N, Beck A, Dumontet C, Denevault-Sabourin C. Antibody-drug conjugates: the last decade. Pharmaceuticals (Basel). 2020;13:245.(Review of the development, structure, efficacy, adverse event rates and approval of vector-based chemotherapy using selective delivery by a monoclonal antibody and cancer cell injury by a conjugated cellular toxin [payload] including nine that are FDA approved and six others in pivotal trials). - PMC - PubMed
1. Powles T, Rosenberg JE, Sonpavde GP, Loriot Y, Durán I, Lee JL, Matsubara N, et al. Enfortumab vedotin in previously treated advanced urothelial carcinoma. N Engl J Med. 2021;384:1125-1135.(Among 608 patients with refractory, locally advanced or metastatic urothelial carcinoma treated with enfortumab vedotin [1.25 mg/kg on days 1, 8 and 15 of 28-day cycles] or standard chemotherapy, median overall survival was 13 vs 9 months and overall response rates were 41% vs 18%, and while adverse event rates were similar, enfortumab treated subjects had a higher rate of serious adverse events [46% vs 44%], peripheral sensory neuropathy {46% vs 31%], hyperglycemia [6.4% vs 0.3%], and withdrawal of therapy for ALT elevations [2% vs 0.3% ]; one patient receiving enfortumab died of hepatic dysfunction [no details provided]). - PMC - PubMed

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[1] Wellstein A, Giaccone G, Atkins MB, Sausville EA. Pathway targeted therapies: monoclonal antibodies, protein kinase inhibitors, and various small molecules. In, Brunton LL Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1203-36.(Textbook of pharmacology and therapeutics).

[2] Wellstein A, Giaccone G, Atkins MB, Sausville EA. Pathway targeted therapies: monoclonal antibodies, protein kinase inhibitors, and various small molecules. In, Brunton LL Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1203-36.(Textbook of pharmacology and therapeutics).

[3] FDA. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761137Orig1s000M...(FDA website with product labels and initial multidiscipline review of enfortumab vedotin mentions that in the total safety cohort of 310 patients, ALT elevations occurred in 34% of patients and were above 5 times ULN in 3%, led to dose interruption in 2%, and discontinuation in 1% but there were no cases of clinically apparent liver injury with jaundice attributed to therapy).

[4] FDA. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761137Orig1s000M...(FDA website with product labels and initial multidiscipline review of enfortumab vedotin mentions that in the total safety cohort of 310 patients, ALT elevations occurred in 34% of patients and were above 5 times ULN in 3%, led to dose interruption in 2%, and discontinuation in 1% but there were no cases of clinically apparent liver injury with jaundice attributed to therapy).

[5] Rosenberg JE, O'Donnell PH, Balar AV, McGregor BA, Heath EI, Yu EY, Galsky MD, et al. Pivotal trial of enfortumab vedotin in urothelial carcinoma after platinum and anti-programmed death 1/programmed death ligand 1 therapy. J Clin Oncol. 2019;37:2592-2600.(Among 125 patients with refractory or relapsed, locally advanced or metastatic urothelial cancer treated with enfortumab vedotin, the objective response rate was 44%, while adverse events occurred in most patients including fatigue in 50%, alopecia 49%, decreased appetite 44%, dysgeusia 40%, and peripheral neuropathy 40%, leading to dose reductions in 32% and discontinuation in 12%; ALT elevations arose in 20% that were above 5 times ULN in 2). - PMC - PubMed

[6] Rosenberg JE, O'Donnell PH, Balar AV, McGregor BA, Heath EI, Yu EY, Galsky MD, et al. Pivotal trial of enfortumab vedotin in urothelial carcinoma after platinum and anti-programmed death 1/programmed death ligand 1 therapy. J Clin Oncol. 2019;37:2592-2600.(Among 125 patients with refractory or relapsed, locally advanced or metastatic urothelial cancer treated with enfortumab vedotin, the objective response rate was 44%, while adverse events occurred in most patients including fatigue in 50%, alopecia 49%, decreased appetite 44%, dysgeusia 40%, and peripheral neuropathy 40%, leading to dose reductions in 32% and discontinuation in 12%; ALT elevations arose in 20% that were above 5 times ULN in 2). - PMC - PubMed

[7] Joubert N, Beck A, Dumontet C, Denevault-Sabourin C. Antibody-drug conjugates: the last decade. Pharmaceuticals (Basel). 2020;13:245.(Review of the development, structure, efficacy, adverse event rates and approval of vector-based chemotherapy using selective delivery by a monoclonal antibody and cancer cell injury by a conjugated cellular toxin [payload] including nine that are FDA approved and six others in pivotal trials). - PMC - PubMed

[8] Joubert N, Beck A, Dumontet C, Denevault-Sabourin C. Antibody-drug conjugates: the last decade. Pharmaceuticals (Basel). 2020;13:245.(Review of the development, structure, efficacy, adverse event rates and approval of vector-based chemotherapy using selective delivery by a monoclonal antibody and cancer cell injury by a conjugated cellular toxin [payload] including nine that are FDA approved and six others in pivotal trials). - PMC - PubMed

[9] Powles T, Rosenberg JE, Sonpavde GP, Loriot Y, Durán I, Lee JL, Matsubara N, et al. Enfortumab vedotin in previously treated advanced urothelial carcinoma. N Engl J Med. 2021;384:1125-1135.(Among 608 patients with refractory, locally advanced or metastatic urothelial carcinoma treated with enfortumab vedotin [1.25 mg/kg on days 1, 8 and 15 of 28-day cycles] or standard chemotherapy, median overall survival was 13 vs 9 months and overall response rates were 41% vs 18%, and while adverse event rates were similar, enfortumab treated subjects had a higher rate of serious adverse events [46% vs 44%], peripheral sensory neuropathy {46% vs 31%], hyperglycemia [6.4% vs 0.3%], and withdrawal of therapy for ALT elevations [2% vs 0.3% ]; one patient receiving enfortumab died of hepatic dysfunction [no details provided]). - PMC - PubMed

[10] Powles T, Rosenberg JE, Sonpavde GP, Loriot Y, Durán I, Lee JL, Matsubara N, et al. Enfortumab vedotin in previously treated advanced urothelial carcinoma. N Engl J Med. 2021;384:1125-1135.(Among 608 patients with refractory, locally advanced or metastatic urothelial carcinoma treated with enfortumab vedotin [1.25 mg/kg on days 1, 8 and 15 of 28-day cycles] or standard chemotherapy, median overall survival was 13 vs 9 months and overall response rates were 41% vs 18%, and while adverse event rates were similar, enfortumab treated subjects had a higher rate of serious adverse events [46% vs 44%], peripheral sensory neuropathy {46% vs 31%], hyperglycemia [6.4% vs 0.3%], and withdrawal of therapy for ALT elevations [2% vs 0.3% ]; one patient receiving enfortumab died of hepatic dysfunction [no details provided]). - PMC - PubMed

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Enfortumab Vedotin

Enfortumab Vedotin

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