FOSTER CITY (dpa-AFX) - Tuesday, Gilead Sciences, Inc. (GILD) announced that the European Commission has granted marketing authorization for Trodelvy, also known as sacituzumab govitecan-hziy, as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer or TNBC.
The approval is based on the findings from the Phase 3 ASCENT-03 study which demonstrated a highly statistically significant and clinically meaningful progression-free survival for Trodelvy compared to standard of care chemotherapy as a first-line treatment.
During the study, Trodelvy also demonstrated a 38% reduced risk of disease progression or death in patients who are not candidates for PD-1/PD-L1 inhibitors.
Additionally, the company has submitted a supplemental filing to the European Medicines Agency for Trodelvy in combination with Keytruda for the treatment of PD-L1 positive unresectable locally advanced or metastatic TNBC.
The supplemental filing is backed by data from the Phase 3 ASCENT-04 study. If approved, Trodelvy will become a potential backbone treatment in 1L metastatic TNBC, across PD-L1 status in Europe.
Meanwhile, the biopharmaceutical company has also submitted supplemental filings to the Food and Drug Administration in the U.S. for Trodelvy for the first-line treatment of adult patients with unresectable locally advanced or metastatic.
In the pre-market hours, GILD is trading at $126.00, up 0.90 percent on the Nasdaq.
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