The FDA has granted approval to sacituzumab govitecan-hziy (Trodelvy®, Gilead Sciences, Inc.) for treatment of unresectable, locally advanced, or metastatic hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancer. Patients are required to have received at least one prior line of endocrine therapy and two systemic therapies in the metastatic setting. "Sacituzumab govitecan is a first-in-class trophoblast cell-surface antigen 2 (Trop-2)–directed antib...

Recently, the FDA granted accelerated approval to sacituzumab govitecan (Trodelvy®, Immunomedics), an antibody-drug conjugate, for patients with locally advanced or metastatic urothelial cancer whose disease progressed following treatment with platinum-containing chemotherapy and a programmed cell death protein 1 (PD-1)/programmed death ligand-1 (PD-L1) inhibitor. In this interview with Oncology Data Advisor, Dr. Petros Grivas, Associate Professor and Clinical Director of the Genitourinary Cance...

Recently, the FDA granted regular approval to sacituzumab govitecan (Trodelvy®, Immunomedics, Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have previously been treated with two or more systemic therapies, at least one of them for metastatic disease. The FDA had previously granted accelerated approval to sacituzumab govitecan based on the results of the phase 1/2 IMMU-132-01 study (NCT01631552); the phase 3 ASCENT study (NCT02574455)...

The FDA has granted regular approval to sacituzumab govitecan (Trodelvy®, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who previously have been treated with two or more systemic therapies, at least one of them for metastatic disease. Previously, the FDA had granted accelerated approval to sacituzumab govitecan based on the results of the phase 1/2 IMMU-132-01 study (NCT01631552); the ASCENT study (NCT0257445...

The FDA recently granted approval to sacituzumab govitecan-hziy (Trodelvy™, Immunomedics, Inc) for patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies. Approval was based on a clinical trial (NCT01631552) that enrolled 108 patients with metastatic TNBC. In an interview with i3 Health, Sara Tolaney, MD, MPH, one of the study authors, provides insights on treating TNBC and the significance of the sacituzumab govitecan approval. What are the ...