Boehringer Ingelheim — Giotrif EMA EPAR variation assessment report (EMEA/H/C/002280, 2013)
Boehringer Ingelheim · 2013 · EMA EPAR variation assessment report
Report summary
This report summarizes the assessment of an extended indication for Giotrif (afatinib) in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) who have progressed after platinum-based chemotherapy. The assessment, primarily based on the LUX-Lung 8 Phase III trial comparing afatinib to erlotinib, demonstrated significant improvements in overall survival and progression-free survival with afatinib. While afatinib was associated with higher rates of diarrhea and stomatitis, these adverse events were manageable through dose reductions. The CHMP recommended approval, concluding that the survival benefits and acceptable toxicity profile resulted in a positive benefit-risk balance for this patient population.
Key findings — cited to the page
| Rash/Acne Grade all (afatinib) | 69.6 % | · p.44 |
| Stomatitis Grade all (afatinib) | 30.1 % | · p.44 |
| Diarrhoea Grade all (afatinib) | 74.7 % | · p.44 |
| Diarrhoea Grade 3/4 (erlotinib) | 3.3 % | · p.44 |
| Rash/Acne Grade 3/4 (afatinib) | 6.6 % | · p.44 |
| Rash/Acne Grade 3/4 (erlotinib) | 10.6 % | · p.44 |
| Grade 3 ADRs: stomatitis | 4.1 % | · p.43 |
| Grade 3 ADRs: decreased appetite | 3.1 % | · p.43 |
| Diarrhoea Grade all (erlotinib) | 41.3 % | · p.44 |
| Diarrhoea Grade 3/4 (afatinib) | 10.7 % | · p.44 |
| Rash/Acne Grade all (erlotinib) | 69.9 % | · p.44 |
| Stomatitis Grade all (erlotinib) | 10.6 % | · p.44 |
Source: Boehringer Ingelheim ↗ · 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 →