Genmab A S — Tivdak EMA EPAR public assessment report (EMEA/H/C/005363, 2025)
Genmab A S · 2025 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) has issued a positive opinion for marketing authorization of Tivdak (tisotumab vedotin) for recurrent or metastatic cervical cancer. The report details the drug's manufacturing, quality control, stability, and non-clinical pharmacology, including its mechanism of action and anti-tumor activity. Comprehensive safety pharmacology, pharmacokinetics, and toxicology studies in various animal models highlight dose-dependent toxicities, particularly affecting bone marrow and lymphoid organs. Clinical studies demonstrate Tivdak's efficacy, showing significant improvements in overall survival and progression-free survival compared to chemotherapy. Key safety concerns include ocular toxicities, peripheral neuropathy, and bleeding events, which are managed through a risk management plan. Despite these adverse effects, Tivdak's benefits in a patient population with limited treatment options are considered to outweigh the risks.
Key findings — cited to the page
| Grade 3 or higher adverse events (anaemia, tisotumab vedotin arm) | 3.6 % | · p.206 |
| Grade 3 or higher adverse events (keratitis, tisotumab vedotin arm) | 2.8 % | · p.206 |
| Grade >=3 AEs (tisotumab vedotin arm) | 8.4 % | · p.205 |
| Grade >=3 AEs (neutropenia, tisotumab vedotin arm) | 3.6 % | · p.205 |
| Grade 3 or higher adverse events (neutropenia, tisotumab vedotin arm) | 3.6 % | · p.206 |
| Grade 3 or higher adverse events (peripheral sensory neuropathy, tisotumab vedotin arm) | 2.8 % | · p.206 |
| treatment-related Grade 3 or higher AEs (p-value) | 0.033 | SGNTV 003 · p.99 |
| treatment-related Grade 3 or higher AEs (p-value) | 0.020 | SGNTV 003 · p.99 |
| Grade >=3 AEs (urinary tract infection, tisotumab vedotin arm) | 4.4 % | · p.205 |
| Grade >=3 AEs (abdominal pain, tisotumab vedotin arm) | 4 % | · p.205 |
| Grade 3 or higher adverse events (fatigue, tisotumab vedotin arm) | 3.6 % | · p.206 |
| Grade >=3 AEs (anaemia, chemotherapy arm) | 27.6 % | · p.206 |
Source: Genmab A S ↗ · 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 →