Boehringer Ingelheim receives CHMP backing for Giotrif label update

Boehringer Ingelheim has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has endorsed a new label update for the cancer drug Giotrif.

The proposed label update would add new data demonstrating the overall survival benefit the drug can provide for patients with EGFR mutation-positive lung cancer, based on additional phase III clinical trial data.

Specifically, the CHMP recommendation includes data from the LUX-Lung 3 and 6 trials, which showed patients whose tumours have the most common EGFR mutation lived more than one year longer when treated with first-line Giotrif compared to standard chemotherapy.

Dr Mehdi Shahidi, medical head for solid tumour oncology at Boehringer Ingelheim, said: "Giotrif is the first and only targeted agent to date to have shown an overall survival benefit for these patients in the first-line setting."

The drug is approved in the EU for the treatment of patients with specific types of EGFR mutation-positive non-small cell lung cancer who have not been treated before with tyrosine kinase inhibitors.