Gilead Sciences, Inc. — Trodelvy EMA EPAR public assessment report (EMEA/H/C/005182, 2021)
Gilead Sciences, Inc. · 2021 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted accelerated assessment for Gilead Sciences' Trodelvy (sacituzumab govitecan) for treating adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) after at least two prior therapies, due to its potential to address an unmet medical need. Manufacturing, non-clinical pharmacology, pharmacokinetics, and toxicology studies supported the application, demonstrating stability, efficacy in xenograft models, and acceptable toxicity profiles. Clinical studies, particularly the Phase 3 IMMU-132-05 trial, showed significant improvements in progression-free and overall survival compared to physician's choice chemotherapy, despite a less favorable safety profile with common hematological and gastrointestinal adverse events. The CHMP concluded a positive benefit-risk balance, recommending marketing authorization for Trodelvy as monotherapy.
Key findings — cited to the page
| Grade 3 or Higher TEAEs (IMMU-132-05 TPC) | 64.7 % | IMMU-132-05 · p.117 |
| Grade 3 or Higher Neutropenia (IMMU-132-05 TPC) | 33.9 % | IMMU-132-05 · p.117 |
| Patients with any Grade 3, 4, or 5 TEAEs (IMMU-132-05 TPC) | 64.7 % | IMMU-132-05 · p.116 |
| Grade 3 or Higher TEAEs (IMMU-132-05 SG) | 72.1 % | IMMU-132-05 · p.117 |
| Grade 3 or Higher Blood and lymphatic system disorders (IMMU-132-05 TPC) | 40.2 % | IMMU-132-05 · p.117 |
| Grade 3 or Higher Neutropenia (IMMU-132-05 SG) | 51.9 % | IMMU-132-05 · p.117 |
| Patients with any Grade 3, 4, or 5 TEAEs (IMMU-132-01 Target TNBC) | 72.2 % | IMMU-132-01 · p.116 |
| Patients with any Grade 3, 4, or 5 TEAEs (IMMU-132-05 SG) | 72.9 % | IMMU-132-05 · p.116 |
| Patients with any Grade 3, 4, or 5 TEAEs (Overall Target TNBC) | 72.7 % | · p.116 |
| Patients with any Grade 3, 4, or 5 TEAEs (All Treated SG) | 75.0 % | · p.116 |
| Grade 3 or Higher Blood and lymphatic system disorders (IMMU-132-05 SG) | 55.8 % | IMMU-132-05 · p.117 |
| Grade 3 or Higher Anemia (IMMU-132-05 SG) | 9.3 % | IMMU-132-05 · p.117 |
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 →