Who is the manufacturer of gosatuzumab?

Sacituzumab govitecan, manufactured by Gilead Sciences and marketed under the brand name Trodelvy, is a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate indicated for the treatment of metastatic triple-negative breast cancer and metastatic urothelial carcinoma. It was approved for medical use in the United States in April 2020 and the European Union in November 2021. In 2022, it was also approved by the National Medical Products Administration and marketed in China and sold under the trade name Tudavi.

The active ingredients of sacituzumab govitecanSacituzumab govitecan is composed of two active ingredients. One is a monoclonal antibody linked to the small molecule SN-38, which recognizes and attaches to Trop-2. Trop-2 is a protein found in many breast cancer cells. When the drug binds to cancer cells, SN-38 becomes active and is taken up by the cells. SN-38 blocks the activity of an enzyme called topoisomerase I, which plays an important role in copying the cellular DNA needed to make new cells. By blocking the action of this enzyme, gosatuzumab prevents cancer cells from multiplying and eventually causes them to die.

The most common side effects of gosatuzumab include nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash, and abdominal pain. Gosatuzumab also carries boxed warnings about the risk of severe neutropenia (abnormally low levels of white blood cells) and severe diarrhea, and may also cause harm to the developing fetus or newborn.