Novartis AG — Afinitor EMA EPAR public assessment report (EMEA/H/C/001038, 2009)
Novartis AG · 2009 · EMA EPAR public assessment report · company profile →
Report summary
Novartis Europharm Ltd. submitted an application to the EMA in July 2008 for marketing authorization of Afinitor (everolimus) for advanced renal cell carcinoma (RCC) that progressed after VEGF-targeted therapy. Afinitor, an orphan medicinal product, was evaluated in the pivotal Phase III study RAD001C2240 (C2240). This randomized, double-blind, placebo-controlled trial demonstrated a statistically significant improvement in progression-free survival (PFS) with everolimus plus Best Supportive Care compared to placebo plus BSC, leading to early termination. While overall survival and objective response rates were not significantly different, the CHMP considered the approximately 3-month PFS benefit clinically relevant. The report details Afinitor's safety profile, including common toxicities and adverse events. Based on the favorable risk-benefit assessment, the CHMP recommended marketing authorization.
Key findings — cited to the page
| Grade 3 or 4 adverse reactions | 39 % | · p.73 |
| Grade 3 or 4 adverse reactions (placebo) | 7 % | · p.73 |
| grade 3 toxicity | 1/12 | · p.34 |
| drug related grade 3 toxicity | 2/12 | · p.34 |
| median OS (placebo) | 14.39 months | · p.73 |
| OS HR | 0.87 | · p.73 |
| median PFS (placebo) | 1.87 months | C2240 · p.73 |
| Male to female ratio for RCC | 1.6:1 | · p.5 |
| median OS | 14.75 months | · p.73 |
| Median age at diagnosis for RCC | 65 years | · p.5 |
| Median age at death for RCC | 71 years | · p.5 |
| CHMP positive opinion date for Marketing Authorisation | 29 May 2009 | Afinitor · p.4 |
Source: Novartis AG ↗ · 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 →