Eli Lilly and Company reports that the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) met to discuss the data supporting the company’s lung-cancer drug, necitumumab in combination with gemcitabine and cisplatin for use in first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC). “We are encouraged by the Committee’s constructive discussion on the benefit-risk profile of necitumumab as few advances have been made over the past two decades in the first-line treatment of advanced squamous NSCLC, leaving a significant unmet medical need,” said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology, in a company statement. “We believe necitumumab with gemcitabine and cisplatin represents a meaningful advance in the search for a new first-line treatment option and look forward to working closely with the FDA as they continue their review.”

The FDA is expected to make a decision on Lilly’s biologics license application for necitumumab later this year.

Necitumumab 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, according to information from Lilly.

Source: Eli Lilly and Company