Tag: HER2
FDA Grants Priority Review for Trastuzumab deruxtecan in HER2 Positive Metastatic...
The U.S. Food and Drug Administration (FDA) has granted Priority Review for Trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki; DS-1062; Enhertu®; Daiichi Sankyo and AstraZeneca) for the...
A Novel Platform for the Generation of Site-Specific Antibody−drug Conjugates
Antibody-drug conjugates (ADCs) combine the superior selectivity of antibodies with the high potency of cytotoxic agents. With 9 approved and commercially available ADCs for...
New Phase I Study Investigates [Vic-]Trastuzumab Duocarmazine + Niraparib in HER2-Expressing...
As part of a new study focusing on advanced targeting human epidermal growth factor receptor-2 (HER2-) expressing cancers, including locally advanced or metastatic solid...
Piramal Pharma Solutions and Bolt Biotherapeutics Sign Production Agreement
Piramal Pharma Solutions, a contract development and manufacturing organization (CDMO) and San Francisco-based biotech Bolt Bioterapeutics have signed a production agreement in which Piramal...
Proof-of-Concept: A Novel Strategy for the Production of Site-specific Antibody-drug Conjugates
Researchers of USC/University of Southern California‘s School of Pharmacy have engineered a new, faster way to develop ADCs. In a study published in Science Advances,...
First Patients Dosed in Phase II Trial with Trastuzumab Duocarmazine in...
A first patient has started treatment in a Phase II study designed to evaluate the safety and efficacy of trastuzumab duocarmazine, also known...
Trastuzumab Duocarmazine Selected to be part of a New Investigational Treatment...
The Quantum Leap Healthcare Collaborative™, a 501c(3) charitable organization established as a collaboration between medical researchers at University of California, San Francisco, and Silicon...
Disitamab Vedotin Shows Clinically Meaningful Response and Survival Benefit in Heavily...
Data from a phase II study of disitamab vedotin (previously known as RC48) shows clinically meaningful results in the treatment of heavily pretreated patients...
Daiichi Sankyo Submits Supplemental New Drug Application for Trastuzumab Deruxtecan in...
In a statement earlier today, Daiichi Sankyo confirmed that it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour...
Highlights in Development: September 2019
In September 2019, a number of articles discussing antibody-drug conjugates were published in a variety of journals. Here is an overview of some of...
