In a report issued Tuesday, the U.S. Food and Drug Administration (FDA) raised concerns that Eli Lilly’s experimental lung cancer drug necitumumab could increase the likelihood of blood clots. The agency found that the drug was associated with a greater chance of overall survival, but that it may also present a higher risk of life-threatening blood clots. Eli Lilly wants to sell the drug as a form of treatment for patients with advanced squamous non-small cell lung cancer, a subset of the most common form of lung cancer, in combination with chemotherapy.
According to Bloomberg, FDA advisers will weigh the pros and cons of the drug on Thursday. A decision on whether not the drug can be sold is expected by the end of the year. FDA staff said in the report that the risk of clotting “in this already high risk population is of concern,” although the safety of necitumumab is on par with similar medications.
The report pointed to one study showing that 9 percent of 538 patients taking necitumumab with chemotherapy suffered from a blood clot. In comparison, 5 percent of 541 patients given chemotherapy only suffered from a blood clot. The FDA report also cited a clinical trial where patients taking the drug lived 1.6 months longer than those receiving chemotherapy only; necitumumab users lived a median of 11.5 months.
According to the American Cancer Society, squamous lung cancer comprises 25 to 30 percent of all lung cancer. Analysts predict that necitumumab will generate $567 million in sales in 2020. The drug would be used as a initial treatment in combination with chemotherapy, unlike Lily’s current non-small cell lung cancer drug Cyramza, which is used for patients whose cancer is worsening despite chemotherapy.