Oncologic Drugs Advisory Committee

The US FDA held an Oncologic Drugs Advisory Committee to discuss biologics license application 125547, necitumumab injection, application submitted by Eli Lilly and Company. The proposed indication for this product is in combination with gemcitabine and cisplatin for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer.

The discussion among the Oncologic Drugs Advisory Committee (ODAC) supported a positive benefit-risk assessment of necitumumab injection, submitted by Eli Lilly and Company, for use in combination with gemcitabine and cisplatin, for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC).