AbbVie Inc. — Elahere EMA EPAR public assessment report (EMEA/H/C/005036, 2024)
AbbVie Inc. · 2024 · EMA EPAR public assessment report · company profile →
Report summary
This report details the marketing authorization application for Elahere (mirvetuximab soravtansine) for FRα-positive, platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer, addressing a significant unmet medical need. Elahere, an antibody-drug conjugate, targets FRα, offering a novel mechanism of action. The report covers its manufacturing, quality control, and stability, confirming a 36-month shelf-life. Non-clinical studies highlighted ocular toxicity and DM4 genotoxicity but showed acceptable environmental risk. Clinical trials (MIRASOL, SORAYA, FORWARD 1) demonstrated superior efficacy for Elahere over chemotherapy, with significant improvements in progression-free and overall survival. While ocular adverse events and pneumonitis were common, they were generally manageable. The overall benefit-risk balance is considered positive for this patient population with poor prognosis.
Key findings — cited to the page
| High-grade serous carcinoma (HGSC) representation in EOC cases | 70 % | · p.13 |
| Grade 3+ leukopenia | 78% | paclitaxel · p.16 |
| Grade 4 neutropenia | 82% | topotecan · p.16 |
| Patients with ≥ Grade 3 severity ocular TEAE | 11 % | · p.200 |
| Grade 4 thrombocytopenia | 30% | topotecan · p.16 |
| Ocular TEAEs (MIRV, All grades) | 417 | · p.171 |
| Patients with ≥ Grade 3 TEAE (IC Chemo, Study 0416) | 54 % | Study 0416 · p.165 |
| Ocular TEAEs (MIRV, All grades) | 59 % | · p.171 |
| Patients with Grade 3 punctate keratitis at 7 mg/kg TBW | 1 patient | Study 0401 · p.92 |
| Patients with ≥ Grade 3 TEAE (MIRV, All Patients) | 337 | · p.165 |
| Patients with ≥ Grade 3 TEAE (IC Chemo, Study 0416) | 112 | Study 0416 · p.165 |
| Patients with ≥ Grade 3 TEAE (MIRV, All Patients) | 48 % | · p.165 |
Source: AbbVie 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 →