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FDA Approves Trodelvy, Breakthrough Treatment For Breast Cancer

Phase 3 trials showed Trodelvy cut disease progression or death risk by 38% in patients not eligible for immunotherapy, Gilead Sciences said.

  • On June 24, the U.S. Food and Drug Administration expanded approval for Trodelvy as a first-line treatment for adults with unresectable locally advanced or metastatic triple-negative breast cancer , Gilead Sciences announced.
  • Triple-Negative breast cancer lacks standard estrogen, progesterone, and HER2 protein targets, making it aggressive and difficult to treat compared to other breast cancer subtypes.
  • Clinical trials showed that Trodelvy-based treatments reduced disease progression risk by 38% compared with chemotherapy alone, targeting the Trop-2 protein found on more than 90% of breast cancer cells.
  • The National Comprehensive Cancer Network now recommends Trodelvy, with or without Keytruda, as a Category 1 preferred first-line treatment, giving doctors greater flexibility to tailor therapy.
  • For Black women, who face a 42% higher mortality rate, Co-Founder and CEO of The Black Breast Cancer Alliance Ricki Fairley emphasizes that this advancement offers renewed hope to a community long underserved by traditional therapies.
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MadameNoire broke the news on Tuesday, June 30, 2026.
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