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
- -
FDA's October 2024 Highlights: Advancing Treatments in Oncology
October 2024 saw significant FDA actions in oncology, including priority reviews for T-DXd in HER2-low/ultra-low breast cancer, acalabrutinib for frontline mantle cell lymphoma, and approvals for nivolumab plus chemotherapy in operable NSCLC, Cologuard Plus for CRC screening, and zolbetuximab for HER2-negative gastric cancer. Other notable actions included fast track designations, orphan drug designations, and expanded approvals for various cancer treatments.
Cancer Antibody Drug Conjugates Market, Drugs Approval & Clinical Trials Report 2024
The Cancer Antibody Drug Conjugates Market report highlights the transformative potential of ADCs in cancer treatment, with 16 approved products and sales exceeding $10B in 2023. The market is projected to surpass $50B by 2030, driven by ongoing clinical trials and increased R&D efforts. Key players include Padcev, Kadcyla, and Enhertu, with significant development activity in lung and breast cancer. The market is led by the US and China, with major pharmaceutical companies driving innovation.
ADCs May Change the Landscape of HER2-Mutant NSCLC
T-DXd showed higher ORRs in HER2-mutated NSCLC, with 55% ORR and 17.8 months median overall survival. HER2-overexpressing patients had 26.5% ORR at 6.4 mg/kg and 34.1% at 5.4 mg/kg, with reduced toxicity. ADCs are moving to the frontline setting, with ongoing trials combining T-DXd with standard treatments. ADCs in NSCLC are progressing, with HER2 emerging as a significant target.
Related Clinical Trials:
2024 Regulatory Approvals Across NSCLC Propel the Therapeutic Landscape Forward
The NSCLC treatment landscape has expanded with FDA approvals, including amivantamab-vmjw plus chemotherapy for EGFR mutations and perioperative durvalumab/nivolumab for resectable NSCLC. Immunotherapy rechallenge is risky due to potential AEs, and ADCs like T-DXd offer alternatives. Amivantamab's dual targeting of EGFR and MET addresses resistance, while perioperative immunotherapy's necessity post-surgery remains uncertain.
Related Clinical Trials:
Thermo Fisher's Oncomine gains FDA approval as brain tumor diagnostic
Thermo Fisher's Oncomine receives FDA approval as a companion diagnostic for grade 2 IDH-mutant glioma, identifying patients eligible for Servier's Voranigo treatment. Voranigo, a once-daily IDH1/IDH2 inhibitor, is the first targeted therapy for this condition, with projected sales of $37m by 2030.
Global Antibody-Drug Conjugate Market Set for a ~USD 26 Billion Surge by 2030
The ADC market, driven by technological advancements and personalized medicine, is expected to reach ~USD 26 billion by 2030 with a CAGR of ~14%. North America leads due to high cancer incidence and strong biopharmaceutical sector. Key players include F. Hoffmann-La Roche Ltd, DAIICHI SANKYO COMPANY, LIMITED, and Pfizer Inc. The market is dynamic, influenced by regulatory frameworks and innovation in linker technologies and payloads.
Oncomine gains FDA approval as brain tumor diagnostic
Thermo Fisher Scientific's Oncomine receives FDA approval for grade 2 IDH-mutant glioma, identifying patients eligible for Servier Pharmaceuticals' Voranigo treatment. Voranigo, a once-daily IDH1/IDH2 inhibitor, is the first targeted therapy for this condition. Oncomine, initially approved in 2017, is also used for NSCLC, CCA, MTC, and TC.
Astellas Pharma Lands a First-in-Class Drug Approval in Rare Gastrointestinal Cancer
Astellas Pharma's zolbetuximab, branded Vyloy, receives FDA approval for first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma expressing CLDN18.2, offering a new targeted therapy for HER2-negative cases. Vyloy, acquired from Ganymede Pharmaceuticals, demonstrated significant improvements in progression-free and overall survival in Phase 3 trials, with common side effects including nausea, vomiting, and decreased appetite.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
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