Lilly Statement on FDA Advisory Committee Review of Necitumumab

The FDA Oncologic Drugs Advisory Committee met today to discuss the data supporting Eli Lilly and Company's necitumumab in combination with gemcitabine and cisplatin.

PRESS RELEASE

INDIANAPOLIS, July 9, 2015 /PRNewswire/ -- The U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) met today to discuss the data supporting Eli Lilly and Company's (NYSE: LLY) necitumumab in combination with gemcitabine and cisplatin for use in first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC).

Squamous NSCLC is a devastating and difficult-to-treat form of lung cancer. The five-year survival rate for patients with metastatic disease is less than five percent.[1] Necitumumab in combination with gemcitabine and cisplatin is the first regimen to show a significant improvement in overall survival over chemotherapy alone, specifically in the first-line setting.

"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. "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.