Novartis AG — Afinitor EMA EPAR variation assessment report (EMEA/H/C/001038, 2009)
Novartis AG · 2009 · EMA EPAR variation assessment report · company profile →
Report summary
Novartis Europharm Ltd sought to extend Afinitor's (everolimus) indication for progressive, unresectable or metastatic, well-differentiated non-functional neuroendocrine tumours (NETs) of gastrointestinal or lung origin. The application included pharmacokinetic data from the T2302 study, showing high inter-subject variability in everolimus levels but no clear exposure-safety relationship for common adverse events. The pivotal RADIANT-4 Phase III study demonstrated significant improvement in progression-free survival with everolimus compared to placebo in advanced GI/lung NETs. However, the everolimus arm showed higher rates of adverse events, serious adverse events, and treatment discontinuations, including non-infectious pneumonitis, infections, and stomatitis. Ongoing pharmacovigilance studies continue to monitor Afinitor's safety profile.
Key findings — cited to the page
| Grade 3 AEs | 21.4 % | · p.56 |
| Grade 3 infections | 7.9 % | · p.58 |
| Grade 3 AEs | 56.9 % | · p.56 |
| Grade 4 AEs | 12.4 % | · p.56 |
| Grade 4 AEs | 7.1 % | · p.56 |
| Grade 4 infections | 3.0 % | · p.58 |
| Grade 3/4 SAEs (placebo) | 14.3 % | · p.78 |
| Grade 3 lymphocytes decreased (everolimus) | 13.4 % | · p.64 |
| Grade 3/4 AEs (placebo) | 28.6 % | · p.78 |
| Grade 4 lymphocytes decreased (everolimus) | 1.5 % | · p.64 |
| Grade 3/4 SAEs | 35.1 % | · p.78 |
| Grade 4 infection | 1.0 % | · p.58 |
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 →