FDA Approves Trodelvy ( sacituzumab govitecan-hziy) for patients with specific metastatic hormone recepter breast cancers having received endocrine-based therapy and at least two additional therapies.

February 3, 2023 - The Food and Drug Administration has approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for 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.

Trodelvy (sacituzumab govitecan-hziy) is a targeted-chemotherapy drug used to treat certain types of breast and urothelial cancers (a type of bladder cancer). Trodelvy is an antibody-drug conjugate containing an antibody called sacituzumab linked to govitecan (SN-38), a chemotherapy drug.

Sacituzumab targets and attaches to a protein called Trop-2, which is overexpressed on the surface of certain cancer cells. The antibody-drug conjugate is then internalized into the cancer cell where the linker between the antibody and drug is broken by a process called hydrolysis, releasing the chemotherapeutic govitecan into the cancer cells.

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