Trastuzumab Deruxtecan: First Approval

Trastuzumab deruxtecan (ENHERTU ® ), a HER2-directed antibody and DNA topoisomerase I inhibitor conjugate, is being developed for the treatment of HER2-expressing solid tumours, including breast cancer, gastric cancer, colorectal cancer and non-small cell lung cancer by Daiichi Sankyo Company Ltd in...

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Veröffentlicht in:Drugs (New York, N.Y.) N.Y.), 2020-04, Vol.80 (5), p.501-508
1. Verfasser: Keam, Susan J.
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description Trastuzumab deruxtecan (ENHERTU ® ), a HER2-directed antibody and DNA topoisomerase I inhibitor conjugate, is being developed for the treatment of HER2-expressing solid tumours, including breast cancer, gastric cancer, colorectal cancer and non-small cell lung cancer by Daiichi Sankyo Company Ltd in collaboration with AstraZeneca. Based primarily on the results of the phase 2 DESTINY-Breast01 trial, trastuzumab deruxtecan was recently approved in the USA under accelerated approval for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. This article summarizes the milestones in the development of trastuzumab deruxtecan leading to this first approval.
doi_str_mv 10.1007/s40265-020-01281-4
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Based primarily on the results of the phase 2 DESTINY-Breast01 trial, trastuzumab deruxtecan was recently approved in the USA under accelerated approval for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. 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source MEDLINE; SpringerLink Journals - AutoHoldings
subjects AdisInsight Report
Agreements
Antibodies
Antineoplastic Agents - chemistry
Antineoplastic Agents - pharmacology
Breast cancer
Camptothecin - analogs & derivatives
Camptothecin - chemistry
Camptothecin - pharmacology
Cell cycle
Clinical trials
Collaboration
Colorectal cancer
Colorectal carcinoma
Deoxyribonucleic acid
DNA
DNA topoisomerase
DNA Topoisomerases, Type I - metabolism
Drug Approval
Drug dosages
Enzymes
ErbB-2 protein
Gastric cancer
Humans
Immunoconjugates - chemistry
Immunoconjugates - pharmacology
Immunotherapy
Internal Medicine
Lung cancer
Medicine
Medicine & Public Health
Metastases
Metastasis
Monoclonal antibodies
Neoplasms - drug therapy
Neoplasms - metabolism
Non-small cell lung carcinoma
Patients
Pharmacology/Toxicology
Pharmacotherapy
Phosphorylation
Small cell lung carcinoma
Solid tumors
Targeted cancer therapy
Topoisomerase I Inhibitors - chemistry
Topoisomerase I Inhibitors - pharmacology
Trastuzumab
Trastuzumab - chemistry
Trastuzumab - pharmacology
Tumors
title Trastuzumab Deruxtecan: First Approval
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