Novartis AG — Zykadia EMA EPAR variation assessment report (EMEA/H/C/003819, 2015)
Novartis AG · 2015 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes a Type II variation application for Zykadia (ceritinib) to extend its indication for first-line treatment of ALK-positive advanced non-small cell lung cancer (NSCLC). Supported by the pivotal Phase III ASCEND-4 study, ceritinib demonstrated significantly improved progression-free survival (PFS) and objective response rate compared to standard chemotherapy. While overall survival data was immature, a positive trend was observed. Pharmacokinetic studies and non-clinical toxicology were also assessed. The safety profile, consistent with previous experience, included common adverse events like GI toxicity and hepatotoxicity, requiring dose modifications. The assessment concluded that ceritinib's benefits, particularly the robust efficacy data from ASCEND-4, outweigh its manageable toxicities.
Key findings — cited to the page
| bradycardia events (all grades, ceritinib, pooled dataset) | 13.1 % | · p.74 |
| grade 3/4 pancreatitis grouped AEs (ceritinib, Study A2301) | 7.9 % | Study A2301 · p.76 |
| grade >= 3 pneumonitis AE (ceritinib, Study A2301) | 0.5 % | Study A2301 · p.72 |
| bradycardia events (all grades, ceritinib, Study A2301) | 15.3 % | Study A2301 · p.74 |
| pancreatitis grouped AEs (all grades, ceritinib, Study A2301) | 11.6 % | Study A2301 · p.76 |
| grade 3 creatinine elevations (ceritinib, Study A2301) | 1.6 % | Study A2301 · p.77 |
| grade 3/4 hepatotoxicity (ceritinib, pooled dataset) | 37.8 % | · p.70 |
| ILD/pneumonitis AEs (all grades, ceritinib, Study A2301) | 2.1 % | Study A2301 · p.72 |
| ILD/pneumonitis AEs (all grades, ceritinib, pooled dataset) | 2.4 % | · p.72 |
| grade 3/4 ILD/pneumonitis AEs (ceritinib, pooled dataset) | 1.3 % | · p.72 |
| grade 3/4 hepatotoxicity (ceritinib, Study A2301) | 49.2 % | Study A2301 · p.70 |
| patients with lipase elevations (any grade, ceritinib, Study A2301) | 11.1 % | Study A2301 · p.77 |
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 →