CHMP Recommends Gilead’s Trodelvy® Plus Keytruda® in PD-(L)1-Positive First-Line Metastatic Triple-Negative Breast Cancer
Gilead announced that the European Medicines Agency's CHMP has adopted a positive opinion recommending marketing authorization for Trodelvy in combination with Keytruda for first-line metastatic triple-negative breast cancer. The recommendation is supported by Phase 3 ASCENT-04 data showing a 35% reduction in the risk of disease progression or death versus standard chemotherapy plus Keytruda in PD-L1 positive patients.
Key figures
- Risk reduction
- 35%
- Pd l1 positive prevalence
- 40%
- Patients treated since 2020
- 75000
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