Gilead Gets FDA Approval for Treatment for Aggressive Form of Breast Cancer
By Kelly Cloonan
Gilead Sciences received approval from the Food and Drug Administration for a treatment for an aggressive form of breast cancer.
The biopharmaceutical company said Wednesday the approval is for Trodelvy for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer, or mTNBC.
The approval was based on Phase 3 trials, where Trodelvy-based regimens reduced the risk of disease progression or death in first-line mTNBC compared with regimens with chemotherapy.
"The FDA's approval of Trodelvy provides a new standard of care for the most aggressive form of breast cancer," Gilead's Chief Medical Officer Dietmar Berger said. "Building on its impact in second-line mTNBC, Trodelvy now offers patients a powerful new backbone therapy option in the first-line setting."
Triple-negative breast cancer is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for about 15% of all breast cancers, Gilead said. Among women with mTNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.
Write to Kelly Cloonan at kelly.cloonan@wsj.com
(END) Dow Jones Newswires
June 24, 2026 17:20 ET (21:20 GMT)
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