FDA approved Trodelvy (sacituzumab govitecan-hziy) for HR+/HER2- Breast CancerFDA approved Trodelvy for a common type of advanced breast cancer.

Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor conjugate. It binds to Trop-2-expressing cancer cells and delivers the topoisomerase inhibitor SN-38, causing DNA damage and cell death.

Trodelvy is indicated for adult patients with unresectable locally advanced or metastatic HR-positive, 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. It is also indicated for mTNBC after two or more prior systemic therapies, at least one for metastatic disease.

The recommended dose is 10 mg/kg intravenously once weekly on Days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity. Do not substitute for or use with other irinotecan-containing drugs. Premedicate for infusion reactions and chemotherapy-induced nausea and vomiting. Primary prophylaxis with G-CSF is recommended for patients at increased risk of febrile neutropenia. Dose reductions are recommended for adverse reactions: first reduction to 7.5 mg/kg, second to 5 mg/kg, then discontinue.

Trial data not available in label.

Warnings include neutropenia (withhold for Grade 3-4 or febrile neutropenia until ANC recovery), severe diarrhea, infusion-related reactions (slow or interrupt infusion for Grade 1-3, discontinue for Grade 4), and nausea/vomiting. Dose modifications are required for Grade 3-4 toxicities. Do not use with other irinotecan-containing drugs.

Trodelvy is a later-line option for HR+/HER2- metastatic breast cancer after endocrine therapy and at least two additional systemic therapies. It is also used in mTNBC after two or more prior therapies.