EU approves Giotrif for NSCLC patients with EGFR mutations

The European Commission has granted marketing authorisation for Giotrif (afatinib), from Boehringer, for the treatment of patients with metastatic Non-Small Cell Lung Cancer whose tumours express specific types of epidermal growth factor receptor (EGFR) gene mutations.

Approval was given on the basis of data from the Phase III LUX-Lung 3 trial which showed that patients on afatinib as a first-line treatment lived for 11.1 months without their tumour growing again versus 6.9 months for those treated with pemetrexed/cisplatin. A further analysis showed that NSCLC patients with tumours containing the EGFR mutations Del19 or L858R experienced median progression-free survival of 13.6 months with the drug, versus a PFS of 6.9 months with the comparator.