FDA panel discusses Lilly's necitumumab

Panelists on FDA's Oncologic Drugs Advisory Committee (ODAC) reviewing a BLA for necitumumab from Eli Lilly and Co. (NYSE:LLY) to treat squamous non-small cell lung cancer (NSCLC) generally agreed that data support a positive benefit-risk assessment of the candidate; however, they remained concerned about adverse events in two Phase III trials. The panel did not vote on any questions.

Necitumumab is under FDA review in combination with gemcitabine and cisplatin as first-line treatment of advanced squamous NSCLC. Lilly spokesperson Carla Cox told BioCentury the company expects regulatory action by YE15. ...