Sanofi — Jevtana EMA EPAR public assessment report (EMEA/H/C/002018, 2011)
Sanofi · 2011 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted marketing authorization for Sanofi-aventis' Jevtana (cabazitaxel) in 2011 for hormone-refractory metastatic prostate cancer previously treated with docetaxel. Preclinical studies demonstrated cabazitaxel's in vitro and in vivo activity, pharmacokinetics, and toxicology, including embryo-foetal toxicity. The pivotal Phase 3 TROPIC study (EFC6193) compared cabazitaxel plus prednisone to mitoxantrone plus prednisone. Cabazitaxel significantly improved overall survival (2.4 months median increase, 30% reduced death risk) and progression-free survival. However, cabazitaxel exhibited a higher incidence of severe adverse events, including myelosuppression and gastrointestinal toxicities, and more treatment-emergent adverse event-related deaths, particularly from neutropenia. Despite increased toxicity, the CHMP recommended authorization due to a favorable benefit-risk balance.
Key findings — cited to the page
| vomiting (all grades) | 22.6 % | EFC6193 · p.55 |
| vomiting (grade >=3) | 0 % | EFC6193 · p.55 |
| diarrhoea (grade >=3) | 0.3 % | EFC6193 · p.55 |
| nausea (grade >=3) | 0.3 % | EFC6193 · p.55 |
| nausea (grade >=3) | 1.9 % | EFC6193 · p.55 |
| vomiting (all grades) | 10.2 % | EFC6193 · p.55 |
| eye disorders (grade >=3) | 0 % | EFC6193 · p.56 |
| ear and labyrinth disorders (all grades) | 3.5 % | EFC6193 · p.56 |
| TEAEs (grade >=3) | 39.4 % | EFC6193 · p.55 |
| ear and labyrinth disorders (grade >=3) | 0 % | EFC6193 · p.56 |
| hepatobiliary disorders (all grades) | 1.6 % | EFC6193 · p.56 |
| vomiting (grade >=3) | 1.9 % | EFC6193 · p.55 |
Source: Sanofi ↗ · 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 →