FDA Approves Sacituzumab Govitecan-hziy for HR+/HER2- Metastatic Breast Cancer

On February 3, 2023, the U.S. Food and Drug Administration approved sacituzumab govitecan-hziy for women 18 years or older with HR+/HER2-Metastatic Breast Cancer refractory to or relapsed after at least 2, and no more than 4, lines of prior systemic therapy.

 

Study ID number: NCT03901339

 

Approval was based on the TROPiCS-02 trial, a multicenter, open-label, randomized clinical trial that included 543 participants with unresectable locally advanced or metastatic HR+/HER2- breast cancers. All the patients had documented disease progression after at least two prior lines of systemic therapy, including at least one hormonal therapy and one CDK4/6 inhibitor therapy. At baseline, selected patients had adequate bone marrow, renal, and hepatic function. Sacituzumab govitecan-hziy was given 10 mg/kg via intravenous (IV) injection on Day 1 and Day 8 of a 21-day cycle until disease progression or unacceptable toxicity.

 

The study demonstrated improved progression-free survival (PFS) with sacituzumab govitecan-hziy compared to the physician’s choice of chemotherapy. Importantly, the study also demonstrated improved overall survival (OS) with sacituzumab govitecan-hziy.

 

When compared, sacituzumab govitecan-hziy showed a PFS of 5.5 months (95% CI: 4.2, 7.0) compared to 4 months (95% CI: 3.1, 4.4) in the single-agent chemotherapeutic arm. Likewise, the patients receiving sacituzumab govitecan-hziy had a median overall survival of 14.4 months compared to 11.2 months in those receiving single-agent chemotherapy.

 

The most common adverse events in patients who received sacituzumab govitecan-hziy included laboratory abnormalities like anemia, neutropenia, and leukopenia; gastrointestinal side effects including diarrhea, nausea, and constipation; and others like alopecia and fatigue.