Amgen Inc. — Vectibix EMA EPAR variation assessment report (EMEA/H/C/000741, 2007)
Amgen Inc. · 2007 · EMA EPAR variation assessment report · company profile →
Report summary
Amgen Europe B.V. submitted a Type II variation for Vectibix (panitumumab) to expand its first-line indication for wild-type RAS metastatic colorectal cancer (mCRC) to include combination with FOLFIRI. The application is supported by a retrospective analysis of Study 20060314 and the investigator-sponsored PLANET study, alongside comparisons to cetuximab's efficacy. The report details panitumumab's safety and efficacy in combination with FOLFIRI or FOLFOX for first-line wild-type RAS mCRC, presenting patient exposure data, adverse event profiles, and a benefit-risk assessment. The report concludes with a recommendation for the extension of indication.
Key findings — cited to the page
| worst grade of 5 adverse events | 4 % | Study 20050181 (Pmab + FOLFIRI arm) · p.22 |
| worst grade of 3 adverse events | 55 % | Study 20050181 (Pmab + FOLFIRI arm) · p.22 |
| worst grade of 4 adverse events | 20 % | Study 20050181 (Pmab + FOLFIRI arm) · p.22 |
| worst grade of 5 adverse events | 6 % | Study 20050181 (FOLFIRI Alone arm) · p.22 |
| worst grade of 4 adverse events | 16 % | Study 20050181 (FOLFIRI Alone arm) · p.22 |
| worst grade of 3 adverse events | 37 % | Study 20050181 (FOLFIRI Alone arm) · p.22 |
| Objective response rate (ORR) for panitumumab plus FOLFIRI in mutant RAS mCRC | 41.10 % | Study 20060314 · p.11 |
| ORR for panitumumab plus FOLFOX in wild-type RAS mCRC with liver metastases (PLANET) | 78 % | PLANET · p.18 |
| Median PFS for panitumumab plus FOLFOX in subjects with liver-limited disease (Study 20050203) | 11.3 months | Study 20050203 · p.18 |
| Median PFS for panitumumab plus FOLFIRI in wild-type RAS mCRC (Study 20060314 vs CRYSTAL) | 11.2 months | Study 20060314 · p.18 |
| ORR for panitumumab plus FOLFIRI in wild-type RAS mCRC with liver metastases (PLANET) | 73 % | PLANET · p.18 |
| ORR for cetuximab plus FOLFIRI in wild-type RAS mCRC (CRYSTAL vs Study 20060314) | 66.3 % | CRYSTAL study · p.18 |
Source: Amgen Inc. ↗ · 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 →