UPDATE: FDA advisory panel informally recommends Lilly's necitumumab but warns on risks

An advisory panel to the US Food and Drug Administration has informally supported approval of necitumumab, an experimental lung cancer drug from Eli Lilly (NYSE: LLY) while recommending mitigating the drug’s risks.

While a formal vote has not been taken, an informal poll indicated most members of the advisory panel believe the benefits of necitumumab outweigh the risks. It found the survival benefit to be modest but meaningful, and consistent with other FDA-approved therapies. Although the FDA is under no obligation to follow the advice of these panels, it generally does.

Lilly is seeking US approval for the recombinant human IgG1 monoclonal antibody in combination with cisplatin and gemcitabine, which it markets as Gemzar, as a first-line treatment for patients with locally advanced or metastatic squamous non-small-cell lung cancer (NSCLC). While the drug improved overall survival by an average of 1.6 months, the FDA acknowledged that it also increases the risk of potentially fatal blood clots and electrolyte imbalances.