Pierre Fabre Medicament — Javlor EMA EPAR public assessment report (EMEA/H/C/000983, 2009)
Pierre Fabre Medicament · 2009 · EMA EPAR public assessment report
Report summary
This report summarizes the EMA's 2008-2009 assessment of Javlor (vinflunine ditartrate) for advanced or metastatic urothelial tract transitional cell carcinoma after platinum-based therapy failure. It details the regulatory process, drug quality, and non-clinical pharmacology, including in vitro/in vivo antitumor activity, toxicology (e.g., bone-marrow toxicity, embryotoxicity), and pharmacokinetics of vinflunine and its active metabolite. The report covers dose adjustments for renal/hepatic impairment and potential drug interactions. Clinical development included Phase I, II, and III studies. The pivotal Phase III trial showed a numerical overall survival advantage for vinflunine + best supportive care, achieving statistical significance in per-protocol and eligible patient populations, alongside improved progression-free survival.
Key findings — cited to the page
| Reduced starting dose for Javlor (WHO/ECOG PS 1 or 0 with prior pelvic irradiation) | 280 mg/m² | Javlor · p.5 |
| Grade 3/4 myelotoxicity rate | 64 % | · p.34 |
| Dose adjustment for Any other toxicity Grade ≥ 3 (except Grade 3 vomiting or nausea) (3rd consecutive event) from 320 mg/m² initial dose | Definitive Treatment discontinuation | · p.29 |
| Dose adjustment for Neutropenia Grade 4 (> 7 days) or Febrile Neutropenia (2nd consecutive event) from 320 mg/m² initial dose | 250 mg/m² | · p.29 |
| Dose adjustment for Neutropenia Grade 4 (> 7 days) or Febrile Neutropenia (3rd consecutive event) from 320 mg/m² initial dose | Definitive Treatment discontinuation | · p.29 |
| Dose adjustment for Mucositis or Constipation Grade 2 (≥ 5 days) or ≥ 3 (any duration) (3rd consecutive event) from 320 mg/m² initial dose | Definitive Treatment discontinuation | · p.29 |
| Starting dose for WHO/ECOG PS 1 or 0 with prior pelvic irradiation | 280 mg/m² | · p.29 |
| Dose adjustment for Neutropenia Grade 4 (> 7 days) or Febrile Neutropenia (first event) from 320 mg/m² initial dose | 280 mg/m² | · p.29 |
| Dose adjustment for Mucositis or Constipation Grade 2 (≥ 5 days) or ≥ 3 (any duration) (first event) from 320 mg/m² initial dose | 280 mg/m² | · p.29 |
| Dose adjustment for Any other toxicity Grade ≥ 3 (except Grade 3 vomiting or nausea) (first event) from 320 mg/m² initial dose | 280 mg/m² | · p.29 |
| Dose adjustment for Any other toxicity Grade ≥ 3 (except Grade 3 vomiting or nausea) (2nd consecutive event) from 320 mg/m² initial dose | 250 mg/m² | · p.29 |
| Dose adjustment for Mucositis or Constipation Grade 2 (≥ 5 days) or ≥ 3 (any duration) (2nd consecutive event) from 320 mg/m² initial dose | 250 mg/m² | · 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 →