Gilead: positives CHMP-Gutachten für Trodelvy + Keytruda in der Erstlinie (1L) bei PD-L1+ mTNBC

CHMP adopted a positive opinion recommending EU marketing authorization for Trodelvy plus Keytruda in PD-L1-positive (CPS ≥10) first-line metastatic TNBC. The European Commission decision is expected later in 2026. This would be a second first-line approval for Trodelvy in metastatic TNBC, expanding its use across PD-L1 status.

Kernfakten

Eingereicht: 24. Juli 2026, 10:26
Ereignis: EMA-Stellungnahme
Richtung: Positiv
Unternehmen: GILDGilead
Asset: sacituzumab govitecan-hziy
Quelle: Unternehmensmitteilung
Belegstatus: Belegt
Risikoreduktion: 35 % reduziertes Risiko für Krankheitsprogression oder Tod

Auszug aus der Quelle

CHMP Recommends Gilead's Trodelvy® Plus Keytruda® in PD-(L)1-Positive First-Line Metastatic Triple-Negative Breast Cancer CHMP Recommends Gilead's Trodelvy® Plus Keytruda® in PD-(L)1-Positive First-Line Metastatic Triple-Negative Breast Cancer CHMP Recommends Gilead’s Trodelvy® Plus Keytruda® in PD-(L)1-Positive First-Line Metastatic Triple-Negative Breast Cancer – A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union – – ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death – Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (

Unternehmensmitteilung