SACITUZUMAB GOVITECAN-HZIY INJ,LYPHL
Clinical Criteria Summary
Indications & Patient Population
- Unresectable locally advanced (LA) or metastatic triple-negative breast cancer (mTNBC)
- Unresectable locally advanced or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer
Prior Therapy Requirements
- mTNBC: Received > 2 prior therapies, with at least one therapy administered in the metastatic setting
- HR+, HER2- BC: Received prior endocrine-based therapy (including a CDK4/6 inhibitor) and > 2 additional systemic therapies in the metastatic setting (one of which must be a taxane)
Dosing & Administration
- 10 mg/kg administered once weekly on Days 1 and 8 of a 21-day cycle
- Continue treatment until disease progression or unacceptable toxicity
Monitoring & Safety Considerations
- Significant toxicity profile (risk of neutropenia, diarrhea, nausea, vomiting) requires appropriate pre-medication, pertinent labs, and monitoring tailored to the patient's clinical context
- Patients homozygous for the UGT1A1*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia; reduced UGT1A1 activity warrants caution
- Avoid concomitant use of UGT1A1 inhibitors or inducers