European regulators have approved Eli Lilly’s Portrazza as a treatment for patients with advanced non-small cell lung cancer (NSCLC).

The drug can be prescribed for use in combination with gemcitabine and cisplatin chemotherapy to treat patients with epidermal growth factor receptor (EGFR) expressing squamous NSCLC who have not received prior chemotherapy for the condition.

The decision gives patients the chance of access to the first biologic approved for this indication, and thereby a new approach for this diificult-to-treat form of lung cancer.

“Little progress has been made in the treatment of squamous non-small cell lung cancer in the first-line setting in the past two decades,” noted Nick Thatcher, professor of medical oncology at Christie Hospital Manchester. 

“Nearly a third of lung cancer patients have this specific, difficult-to-treat type of cancer and a new treatment option will be welcomed by the doctors who are caring for them.”

The approval was based on data from the Phase III SQUIRE trial, which showed that the addition of Portrazza (necitumumab) to gemcitabine and cisplatin chemotherapy improves overall survival in patients, with median survival of 11.5 months vs 9.9 months.