Gilead Trodelvy wins CHMP backing for first-line metastatic triple-negative breast cancer use

Gilead Sciences, Inc.

Gilead Sciences, Inc.

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  • Gilead won a positive CHMP opinion backing EU approval of Trodelvy as a first-line monotherapy for unresectable locally advanced or metastatic triple-negative breast cancer in adults not eligible for PD-1 or PD-L1 inhibitors.
  • The European Commission decision is expected later in 2026.
  • The filing was supported by the Phase 3 ASCENT-03 trial, which showed a 38% reduction in the risk of disease progression or death versus standard chemotherapy.


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