Tag: HER2
Practice-Changing Advances in Early HER2-Positive Breast Cancer: ASCO 2026 and FDA...
Practice-Changing Advances in Early HER2-Positive Breast Cancer: ASCO 2026 and FDA Approvals Establish Trastuzumab Deruxtecan as a New Standard
Antibody-Drug Conjugates in Gastric Cancer: Clinical Progress, Resistance, and the Road...
Antibody-Drug Conjugates in Gastric Cancer: Clinical Progress, Resistance, and the Road Ahead
Disitamab Vedotin as a First-Line Therapy for HER2-Expressing Locally Advanced or...
Disitamab Vedotin as a First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma Reached its Primary Endpoints
Trastuzumab deruxtecan + Pertuzumab Shows Highly Statistically Significant and Clinically Meaningful...
Positive topline results from a planned interim analysis of the phase 3 DESTINY-Breast09 (NCT04784715) trial showed trastuzumab deruxtecan (Enhertu®; Daiichi Sankyo and AstraZeneca)* in combination with pertuzumab (Perjeta®; Genentech/Roche) demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab (Herceptin®; Genentech/Roche) and pertuzumab (THP) as a first-line treatment for patients with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer.
FDA Accepts for Priority Review of sBLA for Gilead’s Sacituzumab Govitecan...
The U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for sacituzumab govitecan-hziy (Trodelvy®; Gilead Sciences)...
Mersana and GSK Sign Option Agreement for the Co-Development and Commercialization...
Mersana Therapeutics and GSK have confirmed that the companies have entered into a global collaboration that provides GSK an exclusive option to co-develop and...
Following Positive Results of Phase III TULIP Trial: FDA Accepts Byondis’...
The U.S. Food & Drug Administration (FDA) has accepted Byondis' submission of a Biologics License Application (BLA) for trastuzumab duocarmazine (previously known as...
FDA Approves Trastuzumab Deruxtecan for Adult Patients with Unresectable or Metastatic...
The U.S. Food and Drug Administration (FDA) has approved fam-trastuzumab deruxtecan-nxki (Enhertu®; Daiichi Sankyo and AstraZeneca) for the treatment of adult patients with unresectable or metastatic HER2...
HER2, Trastuzumab and the Development of Novel Antibody-drug Conjugates
In the mid-1970s, scientists discovered that certain genes, when mutated, can cause cancer. Based on this observation they theorized that by targeting these oncogenes,...
Trastuzumab Deruxtecan Receives Breakthrough Therapy Designation for HER2+ Metastatic Breast Cancer...
The U.S. Food and Drug Administration (FDA) has granted trastuzumab deruxtecan* (Enhertu®; Daiichi Sankyo and AstraZeneca), a HER2 directed antibody-drug conjugate (ADC), Breakthrough Therapy...
