Servier — Onivyde pegylated liposomal (previously Onivyde) EMA EPAR variation assessment report (EMEA/H/C/004125, 2016)
Servier · 2016 · EMA EPAR variation assessment report
Report summary
This report details Servier's Type II variation application for Onivyde pegylated liposomal, seeking approval for first-line treatment of metastatic pancreatic adenocarcinoma. The application is based on the Phase 3 NAPOLI 3 study, which compared Onivyde in combination with oxaliplatin, 5-FU, and leucovorin (NALIRIFOX) against nab-paclitaxel and gemcitabine (Gem+NabP). The NAPOLI 3 study, designed to enroll 750 patients, demonstrated a statistically significant improvement in overall survival (median 11.1 vs 9.2 months, HR 0.84) and progression-free survival (median 7.4 vs 5.6 months, HR 0.69) for NALIRIFOX. Pharmacokinetic and pharmacodynamic analyses, including covariate identification and exposure-response relationships, were also conducted. The report includes environmental risk assessment for the extended indication.
Key findings — cited to the page
| TEAEs Grade 3 and above rate | 90.6% | Study MM-398-07-02-03, pooled population · p.29 |
| diarrhoea, nausea and neutrophil count decreased (Grade 3 and above) rate | 9.4% | Study MM-398-07-02-03, pooled population · p.29 |
| probability of neutropenia Grade 3 and above for median Cavg | 24% | NAPOLI3 study NALIRIFOX treatment arm · p.23 |
| probability of diarrhoea Grade 3 and above for median Cavg | 13% | NAPOLI3 study NALIRIFOX treatment arm · p.23 |
| neutropenia (Grade 3 and above) rate | 31.3% | Study MM-398-07-02-03, pooled population · p.29 |
| febrile neutropenia and hypokalaemia (Grade 3 and above) rate | 12.5% | Study MM-398-07-02-03, pooled population · p.29 |
| probability of neutropenia Grade 3 and above | 17% | NAPOLI3 study NALIRIFOX treatment arm · p.23 |
| probability of neutropenia Grade 3 and above | 79% | NAPOLI3 study NALIRIFOX treatment arm · p.23 |
| probability of diarrhoea Grade 3 and above | 5% | NAPOLI3 study NALIRIFOX treatment arm · p.23 |
| probability of diarrhoea Grade 3 and above | 87% | NAPOLI3 study NALIRIFOX treatment arm · p.23 |
| treatment-related TEAEs Grade 3 and above rate | 68.8% | Study MM-398-07-02-03, pooled population · p.29 |
| neutropenia and neutrophil count decreased (Grade 3 and above) rate | 40.6% | Study MM-398-07-02-03, pooled population · p.29 |
Source: Servier ↗ · 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 →