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 details Gilead Sciences' Type II variation application for Trodelvy (sacituzumab govitecan) to extend its indication for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) based on the phase 3 ASCENT-03 study. It covers the regulatory process, scientific discussion, and clinical aspects. The report outlines bioanalytical methods for sacituzumab govitecan (SG) and its metabolites, population pharmacokinetics, and immunogenicity data. It discusses the impact of anti-drug antibodies on efficacy and safety, and pharmacokinetic/pharmacodynamic modeling. The trial design, statistical methods, and efficacy results (PFS, OS, ORR, DOR) comparing SG to physician's choice chemotherapy are presented, alongside protocol amendments. Finally, the report details Trodelvy's safety profile, including adverse events and those of special interest like neutropenia-related infections and diarrhea.
Key findings — cited to the page
| Median duration of serious infections secondary to neutropenia (any grade) | 13 days | GS-US-592-6238 SG · p.124 |
| Median duration of Grade 3 or higher serious infections secondary to neutropenia | 12 days | GS-US-592-6238 SG · p.124 |
| Serious Infections Secondary to Neutropenia (Grade 3 or higher) | 8 (2.9%) | GS-US-592-6238 SG · p.124 |
| Median time to onset of Grade 3 or higher serious infections secondary to neutropenia | 45 days | GS-US-592-6238 SG · p.124 |
| Participants with any Grade 3 or higher AEs | 181 (65.8%) | GS-US-592-6238 SG · p.113 |
| Neutropenia (Grade 3 or higher) | 118 (42.9%) | GS-US-592-6238 SG · p.113 |
| Diarrhoea (Grade 3 or higher) | 25 (9.1%) | GS-US-592-6238 SG · p.113 |
| Leukopenia (Grade 3 or higher) | 20 (7.3%) | GS-US-592-6238 SG · p.113 |
| Anaemia (Grade 3 or higher) | 12 (4.4%) | GS-US-592-6238 SG · p.113 |
| Febrile neutropenia (Grade 3 or higher) | 12 (4.4%) | GS-US-592-6238 SG · p.113 |
| Lymphopenia (Grade 3 or higher) | 10 (3.6%) | GS-US-592-6238 SG · p.113 |
| Median time to onset of severe (Grade 3 or higher) diarrhoea | 67 days | GS-US-592-6238 SG · p.125 |
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 →