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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.
Featured Image: Women and the power to fight breast cancer Courtesy: © 2017. Fotolia. Used with permission.

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...
General images of ESMO 2019 Congress being held in Barcelona, Spain, September 27 - October 1, 2019. Courtesy European Society for Medical Oncology (ESMO). Used with Permission.

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....
ESMO 2017 - 3

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...

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