Bayer Aktiengesellschaft — Stivarga EMA EPAR public assessment report (EMEA/H/C/002573, 2013)
Bayer Aktiengesellschaft · 2013 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's 2013 assessment of Stivarga (regorafenib) for metastatic colorectal cancer (mCRC) is detailed in this report. Preclinical studies showed kinase inhibition and antitumor activity. The pivotal Phase 3 CORRECT study demonstrated statistically significant, but clinically modest, improvements in overall survival (OS) and progression-free survival (PFS) compared to placebo (1.5 months and 1 week, respectively). However, regorafenib was associated with significant toxicities, including hand-foot syndrome, fatigue, diarrhea, and hypertension, leading to treatment discontinuation. The report emphasizes the need for better patient selection and biomarker identification, particularly for KRAS mutant tumors, given the minimal clinical relevance of the observed efficacy and the drug's safety profile. A risk management plan was outlined to address key safety concerns.
Key findings — cited to the page
| Platelet count decreased (Grade 3) | 2.4 % | 14387 · p.72 |
| Platelet count decreased (All Grades) | 16.8 % | 14387 · p.72 |
| Haemoglobin decreased (Grade 4) | 0 % | 14387 · p.72 |
| Platelet count decreased (All Grades) | 40.5 % | 14387 · p.72 |
| Haemoglobin decreased (Grade 3) | 2.8 % | 14387 · p.72 |
| Platelet count decreased (Grade 4) | 0.4 % | 14387 · p.72 |
| Haemoglobin decreased (Grade 4) | 0.6 % | 14387 · p.72 |
| Lymphocyte count decreased (All Grades) | 54.1 % | 14387 · p.72 |
| Haemoglobin decreased (Grade 3) | 4.7 % | 14387 · p.72 |
| Haemoglobin decreased (All Grades) | 78.5 % | 14387 · p.72 |
| Haemoglobin decreased (All Grades) | 66.3 % | 14387 · p.72 |
| Platelet count decreased (Grade 3) | 0.4 % | 14387 · p.72 |
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 →