US FDA Approves Sacituzumab Govitecan In Pre-treated HR+/HER2- Metastatic Breast Cancer
The U.S. Food and Drug Administration (FDA) has approved sacituzumab govitecan-hziy (Trodelvy®; Gilead Sciences) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
FDA Accepts for Priority Review of sBLA for Gilead’s Sacituzumab Govitecan for Pre-Treated HR+/HER2-...
The U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for...
What to Expect at ESMO 2022: Sacituzumab Govitecan Show PFS Benefits in Patients Diagnosed...
New data from a post hoc subgroup analysis from the Phase 3 TROPiCS-02 study evaluating sacituzumab govitecan-hziy* (Trodelvy®, Gilead...
Combinations with Datopotamab Deruxtecan Show Promising Clinical activity in Treatment of advanced Non-small Cell...
Initial results from the TROPION-Lung02 Phase Ib trial demonstrated that that datopotamab deruxtecan (Dato-DXd), a specifically designed TROP2-directed DXd...
Following Positive Results of Phase III TULIP Trial: FDA Accepts Byondis’ BLA for [Vic-]...
The U.S. Food & Drug Administration (FDA) has accepted Byondis' submission of a Biologics License Application (BLA) for ...
Sacituzumab Govitecan Approved in China for Second-Line Metastatic Triple-Negative Breast Cancer
China's National Medical Products Administration (NMPA) has approved sacituzumab govitecan (Trodelvy®; Gilead Sciences) for the treatment of adult patients with...
Sacituzumab Govitecan Increases PFS for Patients With Most Common Type of Advanced Breast Cancer...
Treatment with sacituzumab govitecan (Trodelvy®; Gilead Sciences), an antibody-drug conjugate (ADC), resulted in longer progression-free survival (PFS) compared to...
TRPH-222 Shows High Response and a Favorable Safety Profile in Non-Hodgkin’s Lymphoma
Updated results from its Phase 1 multi-center, open-label, monotherapy study of TRPH-222 (formerly called CAT-02-106) in heavily pre-treated patients...
A Safer Method of Stem Cell Transplantation may Eliminate need for Chemotherapy and Radiation...
For hard-to-treat leukemias, lymphomas, and other hematological malignancies, hematopoietic stem cell transplantation (HSCT) is the gold standard of care....
Trastuzumab Deruxtecan Receives Breakthrough Therapy Designation for HER2+ Metastatic Breast Cancer in Patients Treated...
The U.S. Food and Drug Administration (FDA) has granted trastuzumab deruxtecan* (Enhertu®; Daiichi Sankyo and AstraZeneca), a HER2 directed...
