Pierre Fabre Medicament — Javlor EMA EPAR variation assessment report (EMEA/H/C/000983, 2009)
Pierre Fabre Medicament · 2009 · EMA EPAR variation assessment report
Report summary
This report summarizes Pierre Fabre Médicament's Type II variation application for Javlor (vinflunine ditartrate) to extend its indication to metastatic breast cancer, specifically in combination with capecitabine for patients previously treated with or resistant to anthracyclines and taxanes. The application included non-clinical and clinical data, notably from the dose-finding study VFL 109 and the Phase III study VFL 305. While VFL 305 showed a statistically significant improvement in progression-free survival (PFS) for the vinflunine-capecitabine combination, no significant overall survival (OS) benefit was observed. The CHMP ultimately recommended refusal of the new indication due to the modest efficacy (1.3-month PFS benefit) and an unfavorable safety profile compared to capecitabine alone, concluding that the benefit-risk balance was negative.
Key findings — cited to the page
| Blood and lymphatic system disorders (any grade) in VFL+CAPE arm | 22.2 % | · p.49 |
| Blood and lymphatic system disorders (any grade) in CAPE arm | 12.0 % | · p.49 |
| Median OS (VFL+CAPE arm) | 13.9 months | VFL 305 · p.29 |
| OS difference | 2.2 months | VFL 305 · p.29 |
| OS Hazard Ratio | 0.98 | VFL 305 · p.29 |
| OS p-value | 0.7657 | VFL 305 · p.29 |
| OS p-value (updated analysis) | 0.6976 | VFL 305 · p.30 |
| OS Hazard Ratio (updated analysis) | 0.97 | VFL 305 · p.30 |
| Median OS advantage (VFL+CAPE vs CAPE) | 2.2 months | VFL 305 · p.30 |
| Risk of death reduction (VFL+CAPE vs CAPE) | 3 % | VFL 305 · p.30 |
| Related case reports in pharmacovigilance database | 222 case reports | Javlor · p.47 |
| Median OS (CAPE arm) | 11.7 months | VFL 305 · p.29 |
Source: Pierre Fabre Medicament ↗ · 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 →