THURSDAY, April 23, 2020 (HealthDay News) -- Accelerated approval has been granted to Trodelvy (sacituzumab govitecan-hziy) to treat patients with metastatic triple-negative breast cancer who have received at least two previous therapies, the U.S. Food and Drug Administration announced Wednesday.
Approval of Trodelvy, a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate, was based on clinical trial data from 108 breast cancer patients with metastatic triple-negative disease. Researchers found an overall response rate of 33.3 percent and a median response duration of 7.7 months. Response was maintained for six months or longer in 55.6 percent of patients who responded, and 16.7 percent of those who responded maintained response for one year or longer.
A Boxed Warning in the prescribing information for Trodelvy warns of the risk for severe neutropenia and severe diarrhea. When taking Trodelvy, patients' blood cell counts should be monitored periodically. To prevent infection, health care professionals should consider treating patients with granulocyte-colony stimulating factor, and they should treat patients with febrile neutropenia with anti-infective treatment.
The FDA also notes that Trodelvy can cause hypersensitivity reactions, including severe anaphylactic reactions. Patients should be monitored for these reactions and should discontinue treatment if severe or life-threatening reactions occur. The most commonly reported side effects with Trodelvy were nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash, and abdominal pain.
Approval was granted to Immunomedics.