Afatinib (3) – Giotrif®

• Clinical trials
  • This was a randomised, actively controlled, open-label, multicentre Phase IIItrial in which afatinib is directly compared with erlotinib in patients with locally advanced or metastatic NSCLC of squamous cell histology who have experienced progression during or after platinum-based chemotherapy and for whom second-line treatment is indicated.

a) Patients with locally advanced and/or metastatic NSCLC with squamous cell histology who have experienced disease progression during or after platinum-based chemotherapy and for whom treatment with docetaxel is indicated

• For patients with locally advanced and/or metastatic NSCLC with squamous cell histology who have experienced progression during or after platinum-based chemotherapy, additional benefit is not proven compared with the appropriate comparator therapy, docetaxel.
• The LUX-Lung 8 study does not allow for a comparison of afatinib with docetaxel, the appropriate comparator therapy specified by the G-BA; furthermore, the pharmaceutical manufacturer has not provided any evidence from which therapeutic equivalence between erlotinib and docetaxel in this therapeutic indication can be reliably inferred.

b) Patients with locally advanced and/or metastatic NSCLC with squamous cell histology who have experienced progression during or after platinum-based chemotherapy, for whom treatment with docetaxel is not indicated

• The pharmaceutical company has not provided any data for the assessment of the additional benefit of afatinib in adult patients with locally advanced or metastatic NSCLC with squamous cell histology who have experienced progression during or after platinum-based chemotherapy and for whom no further chemotherapy is indicated.
• Consequently, additional benefit from afatinib is not proven for this patient group.

Courtesy translation only, please refer to the German original.