德曲妥珠單抗
外观
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单克隆抗体 | |
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种类 | 完整抗体 |
目標 | HER2 |
臨床資料 | |
商品名 | Enhertu |
其他名稱 | DS-8201a, fam-trastuzumab deruxtecan-nxki |
AHFS/Drugs.com | Monograph |
MedlinePlus | a620006 |
核准狀況 | |
懷孕分級 | |
给药途径 | 靜脈注射 |
藥物類別 | 化学疗法 |
ATC碼 | |
法律規範狀態 | |
法律規範 |
|
识别信息 | |
CAS号 | 1826843-81-5 |
PubChem SID | |
DrugBank | |
UNII | |
KEGG | |
ChEMBL | |
化学信息 | |
化学式 | C6460H9972N1724O2014S44.(C52H57F1N9O13)8 |
德曲妥珠單抗(INN:Trastuzumab deruxtecan)全名是曲妥珠单抗ー德鲁替康,用于治疗乳癌和胃癌或胃食道腺癌[11] [12]。主要是針對HER2/neu阳性的疾病[11] [12]。透过静脉緩慢注射[13]。
常见副作用包括恶心、疲倦、脱发、便秘、贫血、白细胞减少症、血小板減少症和头痛[13]。其他副作用包括可能發生低鉀血症、心律不整、間質性肺病和肝脏问题[13]。孕期使用可能對婴儿有害[14]。它是由拓撲異構酶1抑製劑德鲁替康與它连接的单克隆抗体ー曲妥珠单抗結合的組合藥物[13]。曲妥珠单抗會与表皮生长因子受体2(HER2/neu)结合,而德鲁替康则會阻断细胞制造脱氧核糖核酸(DNA)的能力[13]。
德曲妥珠單抗分別於2019年及2020年在美國[11]及日本[15]取得醫療使用許可 。而欧洲和澳大利亚在2021年取得醫療使用許可[13] [14]。
参考文獻
[编辑]- ^ 1.0 1.1 Enhertu. Therapeutic Goods Administration (TGA). 18 October 2021 [22 October 2021]. (原始内容存档于23 October 2021).
- ^ Updates to the Prescribing Medicines in Pregnancy database. Therapeutic Goods Administration (TGA). 21 December 2022 [2 January 2023]. (原始内容存档于3 April 2022).
- ^ AusPAR: Trastuzumab deruxtecan. Therapeutic Goods Administration (TGA). 27 June 2022 [17 July 2022]. (原始内容存档于18 July 2022).
- ^ Enhertu (AstraZeneca Pty Ltd). Therapeutic Goods Administration (TGA). 16 February 2023 [9 April 2023]. (原始内容存档于18 March 2023).
- ^ Summary Basis of Decision (SBD) for Enhertu. Health Canada. 23 October 2014 [29 May 2022]. (原始内容存档于30 May 2022).
- ^ Enhertu 100 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC). (emc). 1 July 2022 [1 July 2022]. (原始内容存档于19 April 2021).
- ^ Enhertu- fam-trastuzumab deruxtecan-nxki injection, powder, lyophilized, for solution. DailyMed. [15 January 2021]. (原始内容存档于22 January 2021).
- ^ Enhertu EPAR. European Medicines Agency (EMA). 9 December 2020 [31 March 2021]. (原始内容存档于23 March 2021).
- ^ Enhertu Product information. Union Register of medicinal products. [3 March 2023]. (原始内容存档于5 March 2023).
- ^ Enhertu approved in the EU for the treatment of HER2-positive metastatic breast cancer (新闻稿). AstraZeneca. 20 January 2021 [21 January 2021]. (原始内容存档于20 January 2021).
- ^ 11.0 11.1 11.2 Fam-Trastuzumab Deruxtecan-nxki Monograph for Professionals. Drugs.com. [10 December 2021]. (原始内容存档于27 December 2021) (英语).
- ^ 12.0 12.1 FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas. U.S. Food and Drug Administration (FDA). 15 January 2021 [15 January 2021]. (原始内容存档于15 January 2021).
本文含有此來源中屬於公有领域的内容。
- ^ 13.0 13.1 13.2 13.3 13.4 13.5 Enhertu EPAR. European Medicines Agency (EMA). 9 December 2020 [31 March 2021]. (原始内容存档于23 March 2021).
- ^ 14.0 14.1 Enhertu. Therapeutic Goods Administration (TGA). 18 October 2021 [22 October 2021]. (原始内容存档于23 October 2021).
- ^ Enhertu Approved in Japan for Treatment of Patients with HER2 Positive Unresectable or Metastatic Breast Cancer (新闻稿). Daiichi Sankyo. 25 March 2020 [21 January 2021]. (原始内容存档于28 January 2021).
延伸閱讀
[编辑]- Iwata TN, Sugihara K, Wada T, et al. [Fam-] trastuzumab deruxtecan (DS-8201a)-induced antitumor immunity is facilitated by the anti-CTLA-4 antibody in a mouse model. PLOS ONE. October 2019, 14 (10): e0222280. Bibcode:2019PLoSO..1422280I. PMC 6772042
. PMID 31574081. doi:10.1371/journal.pone.0222280
.
- Modi S, Saura C, Yamashita T, et al. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N. Engl. J. Med. February 2020, 382 (7): 610–621. PMC 7458671
. PMID 31825192. doi:10.1056/NEJMoa1914510
.
外部連結
[编辑]- Deruxtecan (页面存档备份,存于互联网档案馆) shows structure
- Clinical trial number NCT03329690 for "DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]" at ClinicalTrials.gov
- Clinical trial number NCT03529110 for "DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]" at ClinicalTrials.gov