Necitumumab regulatory update

Panelists on FDA’s Oncologic Drugs Advisory Committee (ODAC) reviewing a BLA for necitumumab from Eli Lilly 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 2 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 said the company expects regulatory action by year end. ...