Mar S A — Yondelis EMA EPAR variation assessment report (EMEA/H/C/000773, 2007)
Mar S A · 2007 · EMA EPAR variation assessment report
Report summary
This report assesses a Type II variation for Yondelis (trabectedin) to include a new indication: combination with pegylated liposomal doxorubicin (PLD) for relapsed platinum-sensitive ovarian cancer. The pivotal Phase III study (ET743-OVA-301) compared trabectedin + PLD to PLD alone. The combination significantly improved progression-free survival (PFS) and objective response rate (ORR). While overall survival (OS) data was maturing, an interim analysis showed a favorable trend for the combination, especially in platinum-sensitive patients. Safety concerns included increased CPK elevations, rhabdomyolysis, and hematologic toxicities (neutropenia, thrombocytopenia) with the combination therapy. Pharmacokinetic data also highlighted potential drug-drug interactions.
Key findings — cited to the page
| Grade 3 or 4 WBC count abnormalities (Caelyx monotherapy arm) | 20 % | ET743-OVA-301 · p.41 |
| Grade 3 or 4 febrile neutropenia (trabectedin + Caelyx arm) | 8 % | · p.48 |
| percentage of patients with grade 3 tumours | 52 % | ET743-OVA-301 · p.14 |
| Grade 3 or 4 WBC count abnormalities (trabectedin + Caelyx arm) | 62 % | ET743-OVA-301 · p.41 |
| Grade 3/4 CPK elevations | 0 % | OVA-301 · p.41 |
| Grade 3 or 4 febrile neutropenia (Caelyx arm) | 2 % | · p.48 |
| Grade 3/4 CPK elevations | 2 % | OVA-301 · p.41 |
| Indication | treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents | Yondelis · p.2 |
| Orphan designation | EU/3/03/171 | trabectedin · EU · p.2 |
| Orphan designation | EU/3/01/039 | Yondelis (trabectedin) · EU · p.2 |
| Investigational arm treatment | Trabectedin 1.1 mg/m2 q3wk 3-h + Caelyx 30 mg/m2 q3wk 1.5-h | ET743-OVA-301 · p.4 |
| Subjects evaluated in investigational arm | 337 | ET743-OVA-301 · p.4 |
Source: Mar S A ↗ · 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 →