Tag: [vic-]trastuzumab duocarmazine
Food and Drug Administration Issues Complete Response Letter for Byondis’ [Vic-]Trastuzumab...
Earlier this week, the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for Byondis' Biological License Application (BLA) for the company's anti-HER2 antibody-drug conjugates [vic-] trastuzumab duocarmazine, also known as SYD985.
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...
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,...
TULIP® Study in Patients With HER2+ Unresectable Locally Advanced or Metastatic...
Results from the Phase III TULIP® study, a multi-center, open-label, randomized clinical trial of Trastuzumab Duocarmazine (SYD985; Byondis Biopharmaceuticals), a next-generation antibody-drug conjugate confirms...
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...
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...
Trastuzumab Duocarmazine Granted U.S. FDA Fast Track Designation for Pre-treated HER2+...
The United States Food & Drug Administration (FDA) has granted Fast Track designation for The Netherlands-based Synthon Biopharmaceuticals investigational anti-HER2 antibody-drug conjugate or ADC...
