Tag: HER2
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...
Chinese Regulator Conditionally Approves Disitamab Vedotin in Advanced or Metastatic Gastric...
Disitamab vedotin (爱地希®/Aidixi®; Previously known as RC48; Remegen Biosciences) has been granted conditional marketing approval by the National Medical Products Administration (NMPA; 国家药品监督管理局) of...
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...
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...
