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ERBITUX
Reason for request
Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer • in combination with chemotherapy,
- as monotherapy in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck
- in combination with radiotherapy in the case of locally advanced disease,
- in combination with platinum-based chemotherapy for recurrent and/or metastatic disease
Clinical Benefit
| Substantial |
As first-line treatment: Alternative drugs are available; The efficacy/adverse effects ratio is moderate; The actual benefit is susbtantial. For second and further lines of treatment: There are very few alternative medications at this stage of the disease; The efficacy/ adverse effects ratio is moderate; The actual benefit is susbtantial. |
Clinical Added Value
| minor |
Based on available data, the Transparency Committee considers that: - as first- and second-line treatment, ERBITUX combined with standard chemotherapy does not improve actual benefit (level V) compared to usual management. - as monotherapy after failure of irinotecan or oxaliplatin-based treatment, ERBITUX provides a minor improvement in actual benefit (level IV) compared to best supportive care alone. |
| no clinical added value |
