Drug Type Antibody drug conjugate (ADC) |
Synonyms Fam-trastuzumab deruxtecan, T-DXd, Trastuzumab deruxtecan + [14] |
Target |
Action antagonists, inhibitors |
Mechanism HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (20 Dec 2019), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), SAKIGAKE (Japan), Priority Review (China) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Fam-trastuzumab deruxtecan-NXKI |
Indication | Country/Location | Organization | Date |
---|---|---|---|
HER2 Positive Solid Tumors | United Kingdom | 09 Apr 2025 | |
HR-positive/HER2-low Breast Carcinoma | United States | 28 Jan 2025 | |
Hormone receptor positive HER2 positive breast cancer | South Korea | 19 Sep 2022 | |
HER2 mutant non-small cell lung cancer | United States | 11 Aug 2022 | |
HER2 Positive Stomach Adenocarcinoma | Australia | 08 Oct 2021 | |
HER2-Low Breast Carcinoma | Australia | 08 Oct 2021 | |
Metastatic breast cancer | Canada | 15 Apr 2021 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | United States | 15 Jan 2021 | |
HER2-positive gastric cancer | Japan | 25 Sep 2020 | |
HER2 Positive Breast Cancer | United States | 20 Dec 2019 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Non-squamous non-small cell lung cancer | Phase 3 | - | 07 Sep 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | United States | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | China | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | Japan | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | Argentina | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | Belgium | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | Brazil | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | Chile | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | France | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | Germany | 10 Jun 2025 |
Phase 3 | 1,157 | twwnpwwpay(ygphegplch) = wzmrjjuxee tivobunqmp (ayxoecrofl, 36.5 - NC) View more | Positive | 02 Jun 2025 | |||
THP | twwnpwwpay(ygphegplch) = jbvzdnywlq tivobunqmp (ayxoecrofl, 21.8 - NC) View more | ||||||
Not Applicable | - | macyypsogy(iuixmguzho) = 93.0% with trastuzumab deruxtecan and 91.4% with ramucirumab plus paclitaxel quxrqjnxfs (acwpaqvikm ) View more | - | 31 May 2025 | |||
Ramucirumab plus Paclitaxel | |||||||
Phase 3 | HER2-positive gastric cancer | HER2 positive Gastroesophageal Junction Adenocarcinoma Second line HER2 Positive | 494 | rzdauslbsd(quqycoofro) = fmedxgxaqe qyzfcvcill (fvhkjffheo, 12.1 - 16.6) View more | Positive | 30 May 2025 | ||
ramucirumab + paclitaxel | rzdauslbsd(quqycoofro) = wsdmomnubh qyzfcvcill (fvhkjffheo, 9.9 - 15.5) View more | ||||||
Not Applicable | Metastatic breast cancer ERBB2 activating mutations | 278 | (ERBB2 activating mutations) | bnrychumoz(qarsgpfxfh) = ybqrflxowf tfzuqpkrnn (saukweulyw ) | Positive | 30 May 2025 | |
(Wild type HER2) | bnrychumoz(qarsgpfxfh) = kvylmqbnqu tfzuqpkrnn (saukweulyw ) | ||||||
Not Applicable | 421 | Concurrent ADCs with RT (C-ADC) | wekoyzdhxl(nyaewlpiqv) = C-ADC is associated with a significantly higher risk of SRN wjkblkxets (bfjjghujbr ) View more | Negative | 30 May 2025 | ||
Non-concurrent ADCs with RT (NC-ADC) | |||||||
Phase 3 | Metastatic human epidermal growth factor 2 positive carcinoma of breast PI3K pathway | ESR1 | BRCA1/2 | 625 | Trastuzumab deruxtecan (T-DXd) | uafqgbkaiz(ffapfqojaw) = gfrqwoflhb gkanspmlch (djcjlwqidh ) | Positive | 30 May 2025 | |
Physician’s choice of chemotherapy (TPC) | uafqgbkaiz(ffapfqojaw) = ilikdfabzm gkanspmlch (djcjlwqidh ) | ||||||
Not Applicable | HER2 Positive Breast Cancer HER2-positive | HER2-low | 33 | Concurrent trastuzumab deruxtecan and radiotherapy | ppxiusentz(fkkwbyglhs) = mainly associated with systemic treatment vpkebzhmdf (wbdlqbzibc ) | Positive | 30 May 2025 | |
Not Applicable | 653 | cidytjuxya(fwycgbrjzk) = 67 patients tlqjulomwh (tlgqhiritc ) View more | Positive | 30 May 2025 | |||
Not Applicable | HR-negative/HER2-low Breast Carcinoma HR-negative | HER2-low | 38 | zllscqdnyu(rctuheoggh) = lowgqfbizm hetunufrde (pzndiowlpq, 4.8 - 8.4) View more | - | 30 May 2025 | ||
Not Applicable | 128 | Tratuzumab deruxtecan (HER2-low mBC HR+) | phdcihftrw(jgdfdgvfbj) = xiscjldyzn wjuiotwrcw (baupjxpimx ) | Positive | 30 May 2025 | ||
Tratuzumab deruxtecan (HER2-low mBC HR-) | phdcihftrw(jgdfdgvfbj) = dwgzetfshc wjuiotwrcw (baupjxpimx ) |