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Gilead's Trodelvy Wins FDA Regular Approval For Triple-Negative Breast Cancer

  • The FDA has granted regular approval to Gilead Sciences Inc’s (NASDAQ: GILD) Trodelvy (sacituzumab govitecan) for an aggressive and tough-to-treat type of breast cancer.
  • The indication covers people with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.
  • Initially, Trodelvy was granted accelerated approval by the FDA in April 2020 and, therefore, needed efficacy to be confirmed in further trials for full approval.
  • The FDA based its full approval on results from the ASCENT trial.
  • Trodelvy showed a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death.
  • Among all patients, median progression-free survival for patients who received Trodelvy was 4.8 months compared to 1.7 months in those who received chemotherapy.
  • Moreover, treatment with Trodelvy was associated with a median overall survival of 11.8 months compared to 6.9 months for those who received chemotherapy.
  • Side effects in more than 25% of patients who received Trodelvy included, but were not limited to, nausea, fatigue, anemia, constipation, rash, and decreased appetite.
  • In March, the European Medicines Agency (EMA) validated the marketing application for sacituzumab govitecan-hziy for triple-negative breast cancer. The application is now under accelerated review by the EMA.
  • Trodelvy, which Gilead had acquired as part of its $21 billion Immunomedics buyout, is an antibody-drug conjugate targeting Trop-2, a protein frequently expressed in multiple types of epithelial tumors.
  • Price Action: GILD shares are up 0.79% at $66.12 in the premarket trading session on the last check Thursday.

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