On April 22, 2020, the FDA approved Trodelvy (sacituzumab govitecan-hziy; from Immunomedics) for the treatment of adults with metastatic (spreading) triple-negative breast cancer, or TNBC, after at least 2 previous therapies.
“Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options. Chemotherapy has been the mainstay of treatment for triple-negative breast cancer. The approval of Trodelvy today represents a new targeted therapy for patients living with this aggressive malignancy,” said Richard Pazdur, M.D., Director of the FDA’s Oncology Center of Excellence.
Trodelvy is a Trop-2–directed antibody and topoisomerase inhibitor drug conjugate, meaning that the drug targets the Trop-2 receptor that promotes the growth and spread of cancer cells, and it is linked to a topoisomerase inhibitor, which kills cancer cells.
About 20% of patients with breast cancers have triple-negative breast cancer, meaning they don’t have any of the 3 biomarkers often seen in breast cancer, including estrogen receptor (or ER), progesterone receptor (or PR), and HER2. Therefore, triple-negative breast cancer doesn’t respond to hormone therapies that target ER, PR, or HER2.
Among the 108 patients included in the clinical trial that led to the FDA approval of Trodelvy, the tumor was shrinking in response to therapy with Trodelvy in about one-third (33%) of the patients. The average duration of the response was 7.7 months, ranging from 6 months to more than 12 months.
The most common side effects with Trodelvy were nausea, neutropenia (reduced white blood cells), diarrhea, fatigue, anemia, vomiting, hair loss, constipation, decreased appetite, rash, and abdominal pain.
