The FDA has approved Trodelvy for two first-line treatment options in adults with advanced or metastatic triple-negative breast cancer (TNBC).
Trodelvy can now be used alone for patients who are not eligible for PD-1 or PD-L1 inhibitor therapy. It is also approved in combination with Keytruda for patients whose tumors have high PD-L1 expression.
The approvals are based on results from two phase 3 studies. In the ASCENT-03 Trial, Trodelvy alone improved median progression-free survival to 9.7 months, compared with 6.9 months for standard chemotherapy. In the ASCENT-04 Trial, Trodelvy plus pembrolizumab extended median progression-free survival to 11.2 months, compared with 7.8 months for chemotherapy plus pembrolizumab. The combination also increased the response rate to 61%, versus 55% with the comparison treatment. Overall survival data are not yet available.
Trodelvy is given as an intravenous infusion at 10 mg/kg on days 1 and 8 of a 21-day treatment cycle. Common side effects were frequent across all treatment groups, and about two-thirds of patients experienced severe side effects. The drug carries a boxed warning for severe diarrhea and low white blood cell counts (neutropenia).