Giotrif (afatinib) is CHMP recommended for treatment of squamous NSCLC- Boehringer

The CHMP has adopted a new indication: Giotrif (afatinib) as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.The approval was based on data from the LUX-Lung 8 trial. Giotrif reached its primary endpoint in the study of significantly delaying the progression of SqCC of the lung when compared against Roche/Astellas' Tarceva (erlotinib). Overall survival was improved by 19% and allowed patients a better quality of life as well as greater control over their cancer symptoms.

Squamous cell carcinoma, which accounts for around 20-30% of NSCLC cases, is associated with a poor prognosis, limited survival and symptoms like cough and dyspnoea. The median overall survival (OS) after diagnosis of advanced SqCC is around one year.