The European Commission approved Eli Lilly's lung cancer med Portrazza, making it the first biologic approved to treat EGFR-expressing squamous non-small cell lung cancer (NSCLC) in the E.U., according to the PharmaTimes.
Portrazza was approved as a first-line treatment in conjunction with certain chemotherapies. The med won approval in the U.S. in November 2015.
- Almost one-third of patients with lung cancer have EGFR-expressing squamous NSCLC.
Portrazza represents an important breakthrough as the first biologic for treatment of EGFR-expressing squamous NSCLC. The approval also is significant because it has some time since a new first-line therapy was introduced for treatment of this type of cancer, as noted by the PharmaTimes.
The approval is based on data from the Phase 3 SQUIRE trial, in which patients treated with Portrazza and standard chemotherapy had an overall survival of 11.5 months versus 9.9 months.