Gilead Sciences, Inc. — Trodelvy EMA EPAR variation assessment report (EMEA/H/C/005182, 2021)
Gilead Sciences, Inc. · 2021 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes Gilead Sciences' Type II variation application for Trodelvy (sacituzumab govitecan) to treat unresectable/metastatic HR+/HER2- breast cancer after prior endocrine therapy and two systemic therapies. Based on the pivotal Phase 3 TROPiCS-02 study, the application details Trodelvy's clinical pharmacology, including PK/PD, immunogenicity, and optimal 10 mg/kg dose selection. Efficacy results demonstrate significant improvements in progression-free survival, overall survival, and objective response rate compared to physician's choice chemotherapy. Safety analyses highlight manageable toxicities, primarily hematological and gastrointestinal, with specific attention to neutropenia and diarrhea. The report concludes with an updated benefit-risk assessment, supporting the expanded indication.
Key findings — cited to the page
| Incidence of Grade 3 or higher Infections | 4.8% % | IMMU-132-09 · p.122 |
| Incidence of Infections (any grade) | 26.9% % | IMMU-132-09 · p.122 |
| Incidence of Grade 3 or higher Infections | 9.7% % | IMMU-132-09 · p.122 |
| Incidence of Grade 3 or higher Diarrhea | 1.2% % | IMMU-132-09 · p.117 |
| Median time to onset of first Grade 3 or higher neutropenia+ event | 15 days | IMMU-132-09 · p.119 |
| Median time to onset of first Grade 3 or higher febrile neutropenia event | 17 days | IMMU-132-09 · p.121 |
| Incidence of Diarrhea (any grade) | 61.9% % | IMMU-132-09 · p.117 |
| Median time to onset of first Grade 3 or higher febrile neutropenia event | 30 days | IMMU-132-09 · p.121 |
| Incidence of Diarrhea (any grade) | 22.9% % | IMMU-132-09 · p.117 |
| Incidence of Grade 3 or higher Diarrhea | 10.1% % | IMMU-132-09 · p.117 |
| Median time to onset of first Grade 3 or higher neutropenia+ event | 16 days | IMMU-132-09 · p.119 |
| Incidence of Neuropathy (any grade) | 16.4% % | IMMU-132-09 · p.122 |
Source: Gilead Sciences, Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →