Tag: HER2-positive
Disitamab Vedotin Gains Approval in China for its Third Indication
Disitamab Vedotin Gains Approval in China for its Third Indication
Trastuzumab deruxtecan Followed by THP Before Surgery Showed Statistically Significant and...
Now positive topline results from a new study, the DESTINY-Breast11 phase 3 trial (NCT05113251), confirmed that trastuzumab deruxtecan (Enhertu®; Daiichi Sankyo and AstraZeneca)**, followed by paclitaxel, trastuzumab and pertuzumab (THP), demonstrated a statistically significant and clinically meaningful improvement in pCR rate versus Standard-of-Care (SoC; dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP]) when used in the neoadjuvant setting in patients with high-risk, locally advanced HER2-positive early-stage breast cancer.
Unlocking the Potential of Antibody-drug Conjugates
One hundred years ago, Paul Ehrlich*, a German biochemist and Nobel laureate who created the field of chemotherapy, coined the term “magic bullet.” He...
Peptide–drug Conjugate Sudocetaxel Zendusortide Shows Potential as a Single Agent and...
Sudocetaxel zendusortide, also known as TH1902, is as novel, investigational peptide-drug conjugate (PDC) candidate being developed by Canadian biotech Theratechnologies as single agent and in combination with other anticancer therapies. The drug targets tumors that express the sortilin (SORT1) receptor.
European Medicines Agency Validates Marketing Authorization Application for Trastuzumab Duocarmazine
The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for Byondis’ investigational next generation anti-HER2 antibody-drug conjugate (ADC) trastuzumab duocarmazine* in patients...
First ‘Intelligent Ligase-dependent Conjugation’ Enabling ADC Receives FDA IND Clearance
This week, GeneQuantum Healthcare, a Suzhou, China-based developer of bioconjugate drugs, confirmed that the company has received an Investigational New Drug (IND) approval for...
IND for RemeGen’s Disitamab Vedotin Marks Important Milestone for the Company’s...
The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application allowing Yantai (Shandong Province; China) -based biopharmaceutical company RemeGen...
Global Phase II Study of DS-8201 in Patients with HER2-Expressing Advanced...
Following initiation of pivotal phase II studies in HER2-positive breast cancer and gastric cancer, the initiation of a third phase II study in colorectal...
Ongoing Phase I Trial of DS-8201 Demonstrates Confirmed Increased Overall Response...
Updated analysis from ongoing phase I study of DS-8201 (trastuzumab deruxtecan), an investigational HER2-targeting antibody-drug conjugate or ADC being developed by Daiichi Sankyo, demonstrated...
Updated Analysis from Ongoing Phase I Trial of DS-8201 Confirms Significant...
About one in five breast cancers overexpress HER2, a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells, which is...
