Cheplapharm — Tarceva EMA EPAR variation assessment report (EMEA/H/C/000618, 2005)
Cheplapharm · 2005 · EMA EPAR variation assessment report
Report summary
This report summarizes a Type II variation application for erlotinib (Tarceva) to restrict its first-line maintenance treatment indication for non-small cell lung cancer (NSCLC) to patients with EGFR-activating mutations. This change is supported by the BO18192 (SATURN) study and a meta-analysis demonstrating significant progression-free survival (PFS) benefits in EGFR-mutated patients. Conversely, the IUNO study (BO25460), which excluded EGFR-mutated patients, showed no overall survival or PFS advantage for early erlotinib. Pooled analyses and studies like ATLAS further confirm erlotinib's efficacy in EGFR-mutated NSCLC. The safety profile remains consistent, with rash and diarrhea as common adverse events.
Key findings — cited to the page
| 6-month PFS rate for placebo | 24 % | BO25460 (IUNO) · p.13 |
| EMA approval date | 19 September 2005 | Erlotinib · EU · p.5 |
| Study BO25460 (IUNO) randomization | 643 patients | BO25460 (IUNO) · Global · p.10 |
| Overall survival HR | 1.02 | BO25460 (IUNO) · p.11 |
| Overall survival 95% CI | 0.85, 1.22 | BO25460 (IUNO) · p.11 |
| Overall survival p-value | 0.8183 | BO25460 (IUNO) · p.11 |
| Median PFS (weeks) for placebo | 12 weeks | BO25460 (IUNO) · p.13 |
| Median PFS (weeks) for erlotinib | 13 weeks | BO25460 (IUNO) · p.13 |
| PFS HR | 0.94 | BO25460 (IUNO) · p.13 |
| PFS 95% CI | 0.80, 1.11 | BO25460 (IUNO) · p.13 |
| PFS p-value | 0.48 | BO25460 (IUNO) · p.13 |
| 6-month PFS rate for erlotinib | 27 % | BO25460 (IUNO) · p.13 |
Source: Cheplapharm ↗ · 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 →