Trodelvy戈沙妥珠单抗 sacituzumab govitecan

Drug Class

Trop-2-directed antibody-drug conjugate

Mechanism

An antibody-drug conjugate (ADC) targeting Trop-2, delivering the topoisomerase I inhibitor SN-38 to induce DNA damage and tumor cell death.

Approved Indication

Treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, or pretreated HR-positive, HER2-negative metastatic breast cancer.

What This Means For Patients

Trodelvy (sacituzumab govitecan) is an antibody-drug conjugate (ADC) approved by the FDA, EMA, and NMPA for triple-negative breast cancer and certain HR+/HER2- breast cancers. It binds to Trop-2 on cancer cells and delivers a chemotherapy payload directly inside them. Patients can access this therapy through clinical pathways in the Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2020) — label
• EMA — approved (2021) — source
• NMPA — approved (2022) — source

Pivotal Clinical Evidence

• ASCENT — Bardia et al., N Engl J Med 2021 (NCT02574455) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761115s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/trodelvy
• https://www.nmpa.gov.cn/