CHMP recommends label update for Giotrif

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for an update to the European label for Boehringer Ingelheim’s Giotrif (afatinib), strengthening and broadening the efficacy profile based on additional Phase III data, the German family-owned pharma major says.

The CHMP recommendation includes data from the LUX-Lung 3 and 6 trials which showed patients whose tumors have the most common EGFR mutation (deletion in exon 19; del19) lived more than one year longer when treated with first-line Giotrif compared to standard chemotherapy (overall survival; OS = secondary endpoint, progression-free survival; PFS = primary endpoint).

Giotrif first drug to show overall survival for this patient population