The European Commission (EC) has approved Gilead Sciences’ Trodelvy (sacituzumab govitecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.
The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products and is based on the Phase 3 TROPiCS-02 study, in which Trodelvy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months versus comparator single-agent chemotherapy. Trodelvy also demonstrated a 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.
“The European approval of sacituzumab govitecan is an important milestone for the European breast cancer community,” said Dr. Javier Cortes, Head of the International Breast Cancer Center, in Madrid and Barcelona, Spain. “We now have a new treatment option that has delivered a proven and clinically meaningful survival benefit for women in Europe with pre-treated HR+/HER2- metastatic breast cancer.”
“Trodelvy could change the outlook for women with pre-treated HR+/HER2- metastatic breast cancer by replacing the standard-of-care chemotherapy that has been their only option for decades,” said Bill Grossman, M.D., Ph.D., Senior Vice President, Therapeutic Area Head, Gilead Oncology. “We look forward to working with European authorities to ensure access for these patients who need new treatment options.”
“Women living with pre-treated HR+/HER2- metastatic breast cancer are focused on time with their loved ones and do not want to worry about running out of treatment options,” said Eva Schumacher-Wulf, Chief Editor, Mamma Mia! Magazine and Metastatic Breast Cancer Patient. “We welcome the approval of this needed new option that gives pre-treated HR+/HER2- metastatic patients the potential for a longer life.”
In the TROPiCS-02 study, Trodelvy also significantly improved additional secondary endpoint measures, including objective response rate and time to deterioration (TTD) assessed by the Global Health Status/Quality of Life and Fatigue scale per EORTC-QLQ-C30. No statistically significant difference in TTD in Pain Scale was observed.
The safety profile for Trodelvy is well-characterized and consistent with prior studies, with no new safety signals identified in this patient population. In TROPiCS-02, the most frequent serious adverse reactions (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), and abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). No patients treated with Trodelvy in TROPiCS-02 experienced interstitial lung disease (ILD). In the TROPiCS-02 study, the discontinuation rate due to adverse reactions was 6% for Trodelvy and 4% for patients on single-agent chemotherapy.
The ESMO Living Guidelines have been updated to include Trodelvy as a category I, A, magnitude of clinical benefit (MCBS) score 3, for women with HR+/HER2- metastatic breast cancer.
Trodelvy is also recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network (NCCN) as defined in the Clinical Practice Guidelines in Oncology (NCCN Guidelines).