FDA panel says benefits outweigh risks for Lilly's lung-cancer drug
The majority of the members of an FDA advisory panel agreed that Eli Lilly's investigational lung-cancer treatment, necitumumab, has a positive risk-benefit ratio.
Panel members described the drug's benefits as incremental but said that its efficacy is similar to other drugs on the market, according to Reuters.
The FDA is not required to follow the panel's recommendation when it decides to approve a product but often does.
In clinical trials, patients taking necitumumab along with chemotherapy lived 1.6 months longer on average than those only taking chemotherapy. But the drug also appeared to raise the risk of fatal blood clots. An independent committee stopped a Phase-III trial early due to a number of patients dying from blood clots while taking necitumumab.