Bayer Aktiengesellschaft — Nexavar EMA EPAR variation assessment report (EMEA/H/C/000690, 2006)
Bayer Aktiengesellschaft · 2006 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the EMA's assessment of Bayer Pharma AG's Type II variation application for Nexavar (sorafenib), seeking an extended indication for differentiated thyroid carcinoma (DTC). The application included updated product information and non-clinical/clinical data. Pharmacokinetic analysis showed higher sorafenib exposure in DTC patients compared to those with hepatocellular or renal cell carcinoma. The pivotal Phase III study (14295) demonstrated a statistically significant improvement in progression-free survival (PFS) and time to progression (TTP) for sorafenib versus placebo in DTC patients, with a median PFS benefit of approximately 5 months. While effective, sorafenib was associated with a higher incidence and severity of adverse drug reactions in DTC patients, including hand-foot skin reaction, hypocalcaemia, and elevated TSH. The Risk Management Plan identified important risks. Despite these safety concerns, the CHMP recommended approval, citing a positive benefit-risk balance, emphasizing the need for careful patient monitoring and dose adjustments.
Key findings — cited to the page
| NOEC for Daphnia sp. Reproduction Test | 0.860 µg/L | Nexavar · p.11 |
| grade 3 hyperglycaemia | 2.9 % | · p.56 |
| prevalence of hypertension (grade 3) | 3 % | · p.52 |
| grade 1 keratoacanthoma (sorafenib) | 6 | · p.55 |
| grade 3 hypocalcaemia | 6.8 % | · p.56 |
| grade 3 ALT | 3.4 % | · p.56 |
| grade 1 keratoacanthoma (placebo) | 1 | · p.55 |
| prevalence of hypocalcaemia (grade 3 or more) | 2 % | · p.52 |
| grade 3 squamous cell carcinoma of skin (sorafenib) | 8 | Study 14295 · p.55 |
| grade 3 squamous cell carcinoma of skin (placebo) | 0 | Study 14295 · p.55 |
| grade 3 hypophosphatemia | 12.6 % | · p.56 |
| grade 3 hyponatraemia | 2.9 % | · p.56 |
Source: Bayer Aktiengesellschaft ↗ · 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 →