Advisory Committee recommends necitumumab to treat advanced squamous NSCLC-Eli Lilly

The FDA Oncologic Drugs Advisory Committee (ODAC) met to discuss the data supporting Eli Lilly and Company's necitumumab in combination with gemcitabine and cisplatin for use in first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC). There was no formal vote however committee members saw the marginal survival advantage (1.6 months overall survival) was enough to recommend approval.

"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.