Merck B V — Erbitux EMA EPAR variation assessment report (EMEA/H/C/000558, 2004)
Merck B V · 2004 · EMA EPAR variation assessment report · company profile →
Report summary
This report details a Type II variation for Erbitux (cetuximab) to restrict its colorectal cancer indication to patients with wild-type RAS tumors. This restriction is based on evidence that mutated RAS proteins bypass EGFR inhibition, causing resistance to anti-EGFR therapy. The CHMP recommended the variation, contingent on Merck KGaA providing further data from the CRYSTAL and FIRE III studies, stratified by RAS status.
Key findings — cited to the page
| PSUR latest data lock point | 30 September 2013 | · p.11 |
| CHMP opinion date | 21 November 2013 | Erbitux · p.5 |
| RMP updated submission due date | 31 March 2014 | · p.13 |
| CRYSTAL and FIRE III studies results submission due date | 31/03/2014 | CRYSTAL and FIRE III studies · p.13 |
| Application for variation submission date | 22 October 2012 | Erbitux · p.4 |
| KRAS exon 2 mutations frequency in CRC | approximately 40% | · p.6 |
| KRAS exon 3 and 4 and NRAS exon 2, 3 and 4 mutations frequency in wild-type KRAS exon 2 CRC | 7% to 22% | · p.6 |
Source: Merck B V ↗ · 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 →