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
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markets.ft.com
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ENHERTU® Receives Prestigious 2024 Prix Galien USA Award for Best Biotechnology Product

Daiichi Sankyo and AstraZeneca awarded 2024 Prix Galien USA for ENHERTU, a HER2-directed ADC, at American Museum of Natural History in New York.
koreabiomed.com
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Alteogen inks $300 mil. deal with Daiichi Sankyo to develop SC version of Enhertu

Alteogen signed an exclusive license agreement with Daiichi Sankyo to develop and commercialize a subcutaneous version of Enhertu, an ADC cancer treatment, using Alteogen’s ALT-B4 technology. Daiichi Sankyo will pay $20 million upfront and up to $280 million in additional payments based on milestones, with royalties on net sales. This marks the first global attempt to convert ADCs into subcutaneous formulations, potentially reducing side effects and improving efficacy.
marketwatch.com
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Cancer Antibody Drug Conjugates Market, Drugs Approval, Price, Sales & Clinical Trials

Antibody drug conjugates (ADCs) are a transformative class in cancer treatment, with 16 approved products and sales exceeding $10B in 2023. The market is expected to surpass $50B by 2030, driven by over 500 ADCs in clinical trials. Key players include Enhertu, Kadcyla, and Padcev, with significant sales in breast and lung cancers. The US and China lead the market, supported by robust R&D and regulatory environments.
onclive.com
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Gynecologic Cancer Paradigm Sees Huge Gains With FDA-Approved Regimens

ESMO 2024 Congress featured updates on ovarian, cervical, and endometrial cancers, including niraparib's long-term PFS benefit, gotistobart's potential in platinum-resistant disease, and T-DXd's tumor-agnostic approval. Checkpoint inhibitors are integrating into cervical and endometrial cancer treatments, with clinical trials showing benefits in PFS and OS. ADCs like tisotumab vedotin and TROP2-directed ADCs are emerging as therapeutic options, particularly in endometrial cancer.
ascopost.com
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Case Study Shows Striking Improvements in Patient With Metastatic Prostate Cancer

A 60-year-old male with stage IV metastatic prostate cancer, unresponsive to multiple therapies, showed a 57% tumor reduction after receiving T-DXd, a HER2-targeted antibody-drug conjugate. The case suggests T-DXd's potential in treating aggressive prostate cancers and the importance of HER2 testing.
targetedonc.com
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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.
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