Patients with a devastating type of lung cancer have fresh hope after the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Eli Lily’s Portrazza (necitumumab).
The drug, which received approval in the US in late November, was recommended 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.
“Today’s news is an encouraging step forward in bringing EU patients a much-needed front-line treatment option for this devastating type of lung cancer, which has a current five-year survival rate of less than five percent in patients with metastatic disease,” said Dr Richard Gaynor, senior vice president of product development and medical affairs for Lilly Oncology. “Very little progress has been made for these patients over the past 20 years and few treatment options are available.”
Following a positive CHMP opinion, the European Commission generally accepts the recommendation and issues a final decision on marketing authorisation within two to three months.
Portrazza is a recombinant human IgG1 monoclonal antibody that is designed to block the ligand binding site of the human epidermal growth factor receptor 1 (EGFR). Activation of EGFR has been correlated with malignant progression, induction of angiogenesis and inhibition of apoptosis, or cell death. As demonstrated in preclinical studies, EGFR plays a role in the formation and spread of tumours.
Lilly stated that the CHMP opinion was based on the results of SQUIRE, an open-label, randomised, multi-centre phase III trial that compared front-line treatment with necitumumab in combination with gemcitabine and cisplatin to treatment with gemcitabine and cisplatin alone in patients with advanced squamous NSCLC.