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FDA Panel Supports Approval Of Eli Lilly's Necitumumab

Eli Lilly and Co (LLY) on Thursday said a panel of the U.S. Food and Drug Administration has supported approval of its investigational 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").

While the FDA is not bound to follow the advice of the Oncologic Drugs Advisory Committee, the agency normally does so.

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.

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, Eli Lilly said.

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

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