Servier — Onivyde pegylated liposomal (previously Onivyde) EMA EPAR public assessment report (EMEA/H/C/004125, 2016)
Servier · 2016 · EMA EPAR public assessment report
Report summary
This EMA report details the regulatory assessment of Onivyde (irinotecan), a pegylated liposomal formulation, for metastatic pancreatic adenocarcinoma. It covers the drug's orphan designation, quality aspects, and pharmaceutical development, noting its light and freezing sensitivity. Non-clinical studies demonstrated Onivyde's improved efficacy, prolonged circulation, and enhanced pharmacokinetic profile compared to free irinotecan, despite similar toxicities (GI, bone marrow). The pivotal NAPOLI-1 trial showed a significant overall survival benefit (1.9 months) and improved progression-free survival when Onivyde was combined with 5-FU/LV. Key safety concerns include myelosuppression and diarrhea, with specific considerations for UGT1A1*28 homozygosity and hepatic impairment.
Key findings — cited to the page
| Reduced Onivyde dose for Grade 3 or 4 diarrhea (second occurrence) | 50 mg/m2 | Onivyde · p.13 |
| Reduced Onivyde dose for Grade 3 or 4 hepatic, renal, respiratory or other toxicities (first occurrence) | 60 mg/m2 | Onivyde · p.13 |
| Reduced Onivyde dose for Grade 3 or 4 neutropenia (second occurrence) | 50 mg/m2 | Onivyde · p.13 |
| Reduced 5-FU dose for Grade 3 or 4 diarrhea (first occurrence) | 1800 mg/m2 | · p.13 |
| Reduced Onivyde dose for Grade 3 or 4 nausea/vomiting (first occurrence) | 60 mg/m2 | Onivyde · p.13 |
| Reduced Onivyde dose for Grade 3 or 4 nausea/vomiting (second occurrence) | 50 mg/m2 | Onivyde · p.13 |
| Reduced Onivyde dose for Grade 3 or 4 neutropenia (first occurrence) | 60 mg/m2 | Onivyde · p.12 |
| Reduced 5-FU dose for Grade 3 or 4 neutropenia (first occurrence) | 1800 mg/m2 | · p.12 |
| Reduced 5-FU dose for Grade 3 or 4 neutropenia (second occurrence) | 1350 mg/m2 | · p.13 |
| Reduced Onivyde dose for Grade 3 or 4 diarrhea (first occurrence) | 60 mg/m2 | Onivyde · p.13 |
| Reduced 5-FU dose for Grade 3 or 4 diarrhea (second occurrence) | 1350 mg/m2 | · p.13 |
| Reduced 5-FU dose for Grade 3 or 4 hepatic, renal, respiratory or other toxicities (first occurrence) | 1800 mg/m2 | · p.13 |
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 →