Eisai Co., Ltd. — Halaven EMA EPAR public assessment report (EMEA/H/C/002084, 2011)
Eisai Co., Ltd. · 2011 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) granted marketing authorization for Eisai Co., Ltd.'s Halaven (eribulin) for metastatic breast cancer, based on a positive CHMP opinion in 2011. Non-clinical studies demonstrated eribulin's potent antiproliferative activity as a microtubule dynamics inhibitor, with expected toxicities like bone marrow suppression. Clinical trials, particularly the EMBRACE study, showed significant improvements in overall survival and progression-free survival compared to physician's choice. Common adverse events included neutropenia and fatigue, with a manageable safety profile across diverse patient populations. Despite potential risks like cardiac arrhythmias and peripheral neuropathy, the clinically meaningful survival benefits outweighed these, leading to the CHMP's recommendation for approval.
Key findings — cited to the page
| incidence of Grade 3 and 4 nausea (BCP) | 1.1 % | · p.55 |
| neutropenia (Grade 3 or higher) | 48.9 % | · p.59 |
| incidence of Grade 3 and 4 leucopenia (BCP) | 14 % | · p.55 |
| incidence of Grade 3 and 4 peripheral neuropathy (BCP) | 6.9 % | · p.55 |
| incidence of Grade 3 and 4 fatigue/asthenia (BCP) | 8.4 % | · p.56 |
| incidence of Grade 3 and 4 mucosal inflammation (BCP) | 1.3 % | · p.56 |
| incidence of Grade 4 neutropenia (eribulin group) | 24.1 % | · p.53 |
| incidence of Grade 3 and 4 neutropenia (BCP) | 48.3 % | · p.55 |
| incidence of Grade 3 and 4 febrile neutropenia (BCP) | 4.6 % | · p.55 |
| incidence of Grade 3 and 4 anaemia (BCP) | 1.4 % | · p.55 |
| incidence of Grade 3 and 4 alanine aminotransferase increased (BCP) | 1.1 % | · p.56 |
| median time to Grade 2 peripheral neuropathy | 85 days | · p.62 |
Source: Eisai Co., Ltd. ↗ · 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 →