FOSTER CITY (dpa-AFX) - Gilead Sciences Inc. (GILD) said Thursday that the U.S. Food and Drug Administration has approved Trodelvy for the first-line treatment of adults with unresectable locally advanced or metastatic Triple-Negative Breast Cancer.
Trodelvy is now approved for first-line metastatic triple-negative breast cancer (mTNBC) as a standalone therapy for patients not eligible for PD-(L)1 inhibitors and in combination with Keytruda for patients with PD-L1-positive disease.
The FDA's decision was supported by data from the Phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19 studies. In ASCENT-03, Trodelvy monotherapy reduced the risk of disease progression or death by 38% compared with chemotherapy in patients ineligible for PD-L1-directed treatment. In ASCENT-04, the combination of Trodelvy and Keytruda reduced the risk of disease progression or death by 35% versus Keytruda plus chemotherapy in patients with PD-L1-positive disease.
Following the positive trial results, the National Comprehensive Cancer Network (NCCN) lists Trodelvy, with or without Keytruda, as a Category 1 preferred first-line treatment option for mTNBC regardless of PD-L1 status. Trodelvy also has a category 1 recommendation in second-line mTNBC and in pre-treated HR+/HER2-negative metastatic breast cancer.
The drug is currently approved in more than 60 countries for second-line or later metastatic triple-negative breast cancer and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.
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