Lilly’s mAb for Lung Cancer Discussed by FDA Advisory CommitteeBy
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