Necitumumab, Eli Lilly & Co.’s lung cancer drug, has been found to increase patients’ risk of potentially deadly blood clots.
In a report released last Tuesday that was viewed by Bloomberg, the U.S. Food and Drug Administration (FDA) said that the drug increased patients’ risks of serious side effects including blood clots. Lilly is seeking to sell necitumumab to treat a subset of the most common type of lung cancer.
The risks and benefits of necitumumab will be the topics of discussion at a meeting of FDA advisers scheduled for Thursday. The drug is used to treat patients with advanced squamous non-small cell lung cancer, in combination with chemotherapy. Bloomberg reports that the FDA is expected to decide if Lilly can sell the drug by the end of the year.
Squamous non-small cell lung cancer accounts for 25 to 30 percent of all lung cancer, according to the American Cancer Society.
One study showed that out of 538 patients taking necitumumab and chemotherapy, nine percent experienced a serious clot, compared with five percent of 541 patients given only chemotherapy, according to the staff report. FDA staff noted that the increased danger of clotting “in this already high risk population is of concern,” according to Bloomberg.
Patients in a clinical trial who took necitumumab lived a median of 11.5 months, 1.6 months longer than those who got only chemotherapy, the FDA staff report said. Analysts estimate that if the agency approves the drug, it could generate $567 million in sales in 2020, Bloomberg reports.
Lilly already sells a medication to treat non-small cell lung cancer known as Cyramza. The drug is approved for use in patients whose cancer is progressing, despite chemotherapy, according to Bloomberg.