EU approves Portrazza (necitumumab) to treat squamous EGFR expressing NSCLC.- Eli Lilly

Eli Lilly announced that the European Commission has granted a marketing authorisation for necitumumab (Portrazza), for use in combination with gemcitabine and cisplatin chemotherapy for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy for this condition. Necitumumab is the first biologic licensed in the EU as a first-line treatment option for this indication.

Comment: This authorisation is based on the results of the SQUIRE trial, an open-label, randomised, multi-center Phase III trial that compared first-line treatment with necitumumab in combination with gemcitabine and cisplatin to treatment with gemcitabine and cisplatin alone in patients with advanced squamous NSCLC. This is the first authorisation for necitumumab in Europe and follows FDA approval in November 2015.