Trastuzumab deruxtecan
- Generic Name
- Trastuzumab deruxtecan
- Brand Names
- Enhertu
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1826843-81-5
- Unique Ingredient Identifier
- 5384HK7574
- Background
Trastuzumab deruxtecan is a HER-2 directed antibody attached to a topoisomerase inhibitor that is approved for use in certain types of metastatic, unresectable breast cancer. It is classified as an antibody-drug conjugate. The cleavable peptide linker used to bind the antibody and drug in this product distinguishes it from other members of its class. Trastuz...
- Indication
In the US, trastuzumab deruxtecan is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. It...
- Associated Conditions
- Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Adenocarcinoma, Metastatic Breast Cancer, Metastatic Breast Cancer With HER2 Positive, Unresectable Breast Cancer, Locally advanced HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Locally advanced HER2-positive Gastric Adenocarcinoma, Metastatic HER2 Mutant Non-small Cell Lung Cancer, Metastatic HER2-low Breast Cancer, Metastatic HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Metastatic HER2-positive Gastric Adenocarcinoma, Unresectable HER2 Mutant Non-small Cell Lung Cancer, Unresectable HER2-low Breast Cancer, Unresectable HER2/Neu-positive Breast Cancer
- Associated Therapies
- -
Phase 3 Trial Data Inform Advancements in Targeted Therapy for Gastric/GEJ Cancers
Cindy M. Pabon, MD, discusses updated efficacy and safety findings from 3 trials in gastric and gastroesophageal cancer: TOPGEAR (preoperative radiotherapy), KEYNOTE-811 (pembrolizumab plus trastuzumab and chemotherapy), and DESTINY-Gastric03 (fam-trastuzumab deruxtecan-nxki). These studies highlight the shift towards targeted and systemic treatments, balancing efficacy with toxicity, and the importance of long-term survival outcomes over pathologic complete response rates.
Related Clinical Trials:
Tagrisso recommended for approval in the EU by CHMP for patients with unresectable ...
Lung cancer is a leading cause of cancer death globally, with NSCLC being the most common type. LAURA is a Phase III trial testing Tagrisso, a third-generation EGFR-TKI, in Stage III EGFRm NSCLC patients. Tagrisso has shown efficacy in various stages of NSCLC and is part of AstraZeneca's comprehensive lung cancer portfolio. The company aims to redefine cancer care and eliminate it as a cause of death.
Navigating a “Sea Change” in Frontline Urothelial Carcinoma Treatment
Urothelial carcinoma treatment has evolved with FDA approvals of enfortumab vedotin-ejfv + pembrolizumab and nivolumab + cisplatin/gemcitabine. Personalized therapy is crucial as patients now live longer, but toxicity remains a challenge. Circulating tumor DNA (ctDNA) may help tailor treatment, and ongoing research explores combinations like sacituzumab govitecan + enfortumab vedotin. The landscape is rapidly changing, emphasizing the need for more biomarker research to guide treatment selection.
Related Clinical Trials:
T-DXd Sequencing and Treatment Options in the Tumor-Agnostic Setting
Experts at the IASLC World Conference on Lung Cancer discussed HER2-directed treatments, highlighting recent approvals and clinical trial updates. They emphasized the importance of biomarker testing and safety profiles of HER2-targeted agents across cancer types. The panel debated the use of T-DXd in different lines of therapy for HER2-mutated non-small cell lung cancer (NSCLC) and the potential of TKIs like zongertinib and BAY 2927088. They also explored the implications of HER2 expression in tumor-agnostic trials and the role of AI in predicting patient responses.
Related Clinical Trials:
AstraZeneca, Daiichi Sankyo seek US FDA's accelerated approval for datopotamab
AstraZeneca and Daiichi Sankyo submitted a new BLA for datopotamab deruxtecan for EGFR-mutated NSCLC, withdrawing a previous BLA for nonsquamous NSCLC. The decision was based on FDA feedback and trial data showing pronounced benefits for EGFR-mutated patients.
AstraZeneca's Contribution to the Breast Cancer Market
AstraZeneca's Enhertu gains EMA approval for HER2-positive breast cancer, improving progression-free survival. Early detection in the U.S., Canada, and Europe boosts survival rates. The global breast cancer market, valued at USD 31.51 billion in 2024, is projected to reach USD 73.68 billion by 2032. Targeted therapies dominate, with North America leading due to advanced healthcare infrastructure and strong research funding.
New blood test detects early lung damage in cancer patients on targeted therapy
New blood test detects early lung damage in cancer patients on antibody-drug conjugates (ADCs), offering non-invasive monitoring for drug-induced lung disease.
Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients
Datopotamab deruxtecan, an investigational TROP2-directed ADC, is being evaluated in multiple clinical trials for advanced NSCLC, including TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01. These trials assess efficacy and safety in patients with actionable genomic alterations and those requiring systemic therapy following prior treatment. Primary endpoints include objective response rate (ORR) and progression-free survival (PFS). AstraZeneca and Daiichi Sankyo collaborate on the development and commercialization of datopotamab deruxtecan.
Related Clinical Trials:
AstraZeneca, Daiichi revise approval plans for Enhertu successor
AstraZeneca and Daiichi Sankyo withdrew an approval application for lung cancer drug dato-dxd, replacing it with a new one targeting EGFR-mutated tumors, aiming for an 'accelerated' approval in previously treated patients. This decision, based on pooled analysis showing pronounced benefit in EGFR-mutated patients, could limit the drug's sales potential.
Astra Invests $3.5 Billion in US as Cancer Drug Lifts Sales
AstraZeneca raised its annual forecast due to strong cancer drug sales and plans $3.5B investment in US by 2026. Tagrisso and Enhertu outperformed, while Dato-DXd faced FDA setback. China sales growth slowed amid import probe. Astra aims for $80B in sales by 2030, driven by cancer drugs.
Drug Development Updates
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