NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended Gilead Sciences' antibody-drug conjugate Trodelvy (sacituzumab govitecan) for advanced hormone receptor (HR)-positive, HER2-negative breast cancer patients after treatment with an endocrine-based therapy and at least two other systemic therapies.
The recommendation is based on the results of the Phase III TROPiCS-02 study in which Trodelvy improved patients' overall survival versus chemotherapy. Patients treated with Trodelvy lived a median of 14.4 months, whereas patients who received single-agent chemo lived a median of 11.2 months. Trodelvy also led to a 34 percent reduction in patients' risk of disease progression or death.
Gilead expects the European Commission to decide later this year whether to follow CHMP's recommendation and approve Trodelvy in this setting.
Gilead also said on Friday that the European Society for Medical Oncology has updated its guidelines to include Trodelvy as a category I preferred treatment for HR-positive, HER2-negative metastatic breast cancer patients.
In the US, the National Comprehensive Cancer Network also recommends Trodelvy as a category 1 treatment in this setting, and the US Food and Drug Administration approved the treatment for this patient population in February.