FDA Approves Gilead’s TrodelvyⓇ

Gilead Sciences, Inc. (Nasdaq: GILD) has been granted FDA approval for Trodelvy for the treatment of HR+/HER2- metastatic breast cancer.

Trodelvy demonstrated overall survival and quality of life benefit in breast cancer patients who had received prior endocrine-based therapy and at least two chemotherapies.


  • In Gilead’s TROPiCS-02 study, Trodelvy demonstrated a statistically significant and clinically meaningful overall survival benefit of 3.2 months versus comparator chemotherapy.
  • It also showed 34% reduction in risk of disease progression or death.
  • Three times as many people treated with Trodelvy were progression-free at one year versus those treated with chemotherapy.
  • Trodelvy has improved survival in both pre-treated HR+/HER2- metastatic breast cancer and in second-line metastatic triple-negative breast cancer.
  • Trodelvy is now recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network®.

Trodelvy is approved in more than 40 countries for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer.

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FDA Approves Gilead’s TrodelvyⓇ

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