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 Approves Companion Diagnostic To Identify Patients With Grade 2 IDH-Mutant Glioma
The FDA approved Thermo Fisher Scientific's Ion Torrent Oncomine Dx Target Test as a companion diagnostic for vorasidenib, an IDH1/IDH2 inhibitor for grade 2 astrocytoma or oligodendroglioma. This marks the first targeted therapy for grade 2 IDH mutant glioma, addressing an unmet need in brain cancer treatment.
FDA approves Astellas' gastric cancer therapy
FDA approves Astellas' Vyloy therapy for gastric cancer, available in 6-12 business days at $1600 per 100 mg vial. Vyloy, a monoclonal antibody, improves survival in late-stage trials and is the first targeted therapy for a specific protein family in gastric cancers.
Breast cancer patients denied life-extending drug in NHS row
Breast cancer patients denied Enhertu, a life-extending drug, due to cost concerns by NICE, despite its availability in 19 European countries. Jeannie Ambrose, one of 1,000 affected, argues for its NHS funding, hoping for extra time with her family.
Emerging HER2-Targeted Therapies in NSCLC: Zongertinib and BAY 2927088
Advances in precision medicine have transformed NSCLC treatment, with broad molecular testing now recommended. HER2 mutation, present in 3% of NSCLC patients, is associated with aggressive disease and brain metastases. No first-line HER2-targeted therapies are approved; current options include immunotherapy and platinum doublet. Zongertinib and BAY 2927088, oral HER2-targeted TKIs, show promise in pre-treated patients, with zongertinib demonstrating a 66.7% ORR and BAY 2927088 showing a 72.1% ORR. Both agents have been granted breakthrough therapy designation by the FDA.
Related Clinical Trials:
A promising antibody-drug conjugate for treating brain metastases in breast cancer patients
Despite therapeutic advancements, breast cancer remains a significant health issue, particularly due to metastasis. Trastuzumab deruxtecan (T-DXd) shows promise in treating brain metastases (BM) in HER2-positive breast cancer patients, with improved intracranial objective response rates and duration of response compared to other treatments, according to a study by Dr. Sara Hurvitz and her team.
T-DXd Demonstrates Efficacy in HER2+ Metastatic Breast Cancer With Stable or Active Brain Metastases
DESTINY-Breast12 trial findings support T-DXd efficacy in HER2-positive breast cancer with active or stable brain metastases, showing 61.6% 12-month PFS and 17.3-month median PFS.
Dr Lee on the Significance of the Tumor-Agnostic Approval of T-DXd for HER2+ Urothelial Cancer
The FDA granted accelerated approval to T-DXd for unresectable or metastatic HER2-positive solid tumors, supported by phase 2 trials showing significant efficacy across various HER2-positive solid tumors. T-DXd demonstrated higher response rates and progression-free survival benefits in HER2-positive IHC 3+ tumors, making it a promising therapeutic option for patients with no satisfactory alternative treatments.
Related Clinical Trials:
Enhertu approved in China as first HER2-directed therapy for patients with ...
AstraZeneca and Daiichi Sankyo's Enhertu receives conditional approval in China for treating HER2-mutant NSCLC, based on DESTINY-Lung02 and DESTINY-Lung05 trials. Full approval pending confirmatory trial results.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
© Copyright 2024. All Rights Reserved by MedPath