Antibody-Drug Conjugate Receives FDA Approval in Metastatic Triple-Negative Breast Cancer
Posted: Friday, April 24, 2020
On April 22, the U.S Food and Drug Administration (FDA) granted accelerated approval for sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with metastatic triple-negative breast cancer. Patients must have received at least two prior therapies. Sacituzumab govitecan-hziy is the first antibody-drug conjugate approved by the FDA specifically for this type of breast cancer. It is a Trop-2–directed antibody and topoisomerase inhibitor.
The accelerated approval is based on the results of the single-arm phase II IMMU-132-01 clinical trial. The study enrolled 108 patients with triple-negative breast cancer who had a median of three prior systemic therapies. Patients given the study drug had a 33.3% objective response rate, with a median duration of response of 7.7 months. In addition, 55.6% of patients maintained their response for 6 or more months, and 16.7% maintained their response for 12 or more months.
The most common side effects (in at least 25% of patients) reported with sacituzumab govitecan-hziy included nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash, and abdominal pain. The most common grade 3 or 4 adverse events (occurring in more than 5% of patients) were neutropenia, decrease in white blood cell count, anemia, hypophosphatemia, diarrhea, fatigue, nausea, and vomiting. The prescribing information for sacituzumab govitecan-hziy includes a Boxed Warning to advise health-care professionals and patients about the risk of severe neutropenia and severe diarrhea.
