Gilead Receives EMA’s CHMP Positive Opinion of Trodelvy (sacituzumab govitecan) for Pre-Treated HR+/HER2- Metastatic Breast Cancer
- The EMA’s CHMP has adopted a positive opinion for Trodelvy as monotx. for adult patients with unresectable or metastatic HR+, HER2- breast cancer. The EC’s decision on an additional indication is expected in 2023
- The opinion was based on the P-III study (TROPiCS-02) evaluating Trodelvy vs CT in 543 patients which showed a clinical OS benefit of 3.2mos., m-OS (14.4 vs 11.2mos.), 34% reduction in risk of disease progression or death, m-PFS (5.5 vs 4.0mos.), patients were progression-free at 1yr. (21% vs. 7%)
- The therapy showed improved additional 2EPs measures, incl. ORR & TTD with no significant difference in TTD in pain scale. The safety profile was consistent with prior studies with no new safety signals, treatment discontinuation rate due to adverse reactions was 6% vs 4%
Ref: Gilead | Image: Gilead
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