EU approves Gilead Trodelvy as first-line treatment for metastatic triple-negative breast cancer patients ineligible for PD-(L)1 inhibitors

Gilead Sciences, Inc.

Gilead Sciences, Inc.

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  • European Commission granted marketing authorization for Gilead’s Trodelvy as first-line monotherapy in metastatic TNBC for patients not eligible for PD-1/PD-L1 inhibitors.
  • Decision drew on Phase 3 ASCENT-03 data showing a 38% reduction in risk of progression or death versus standard chemotherapy.
  • EMA is reviewing a separate filing for Trodelvy with Merck’s Keytruda in PD-L1-positive metastatic TNBC.


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