FDA staffers raise flags over blood clot risk in Lilly's necitumumab

The US Food and Drug Administration has posted briefing documents prepared by staffers on its website saying that Eli Lilly’s (NYSE: LLY) necitumumab extended overall survival but also raised the risk of potentially fatal thromboembolic events.

The documents relating to Lilly’s investigational lung cancer drug, posted ahead of an advisory panel meeting on July 9, showed an increase in thromboembolic events in the necitumumab arm compared to standard chemo.

Lilly is seeking approval in the USA for the recombinant human IgG1 monoclonal antibody in combination with cisplatin and gemcitabine, marketed as Gemzar, as a first-line treatment for locally advanced or metastatic squamous non-small cell lung cancer (NSCLC).