Boehringer Ingelheim's Gilotrif could be leading therapy if it overcomes concerns, says GlobalData

Family-owned German drug major Boehringer Ingelheim could face “significant challenges” over its first-line treatment of EGFR-mutated non-small cell lung cancer (NSCLC), despite receiving approval from the US Food and Drug Administration last week ( The Pharma Letter July 15), according to research and consulting firm GlobalData.

Boehringer must strive for second-line marketing authorization for the latest EGFR-targeting drug Gilotrif (afatinib) if it is to meet sales potential, says GlobalData analyst Brooke Baker.

Dr Baker said: “There are concerns regarding Gilotrif’s toxicity among some in the NSCLC space, and indeed Gilotrif’s FDA prescribing information carries a warning against severe diarrhea. We believe these safety concerns, combined with a lack of head-to-head data against entrenched anti-EGFR therapies such as Tarceva, could limit Gilotrif’s uptake in the US NSCLC market starting from 2013.”