Experimental New Lung Cancer Drug Ups Patients’ Risk of Deadly Blood Clots

An experimental lung cancer drug known as necitumumab may increase patients’ risk of suffering deadly blood clots.

The maker of the drug, Eli Lilly & Co., recently notified the U.S. Food and Drug Administration (FDA) about its concerns. The company wants to sell necitumumab to treat squamous non-small cell lung cancer, which is one of the most common types of the disease. The FDA will meet today to discuss the risks and benefits of the drug when used in combination with chemotherapy. The agency is expected to decide if Lilly can sell the drug by the end of the year, according to Bloomberg.

While the safety of necitumumab reflects that of similar drugs, the increased danger of clotting “in this already high risk population is of concern,” FDA staff wrote in a report released Tuesday that was viewed by Bloomberg.

In one study, nine percent of the 538 patients taking necitumumab and chemotherapy experienced a serious blood clot, compared with five percent of 541 patients given only chemotherapy, the FDA staff report showed. Patients in a clinical trial who took necitumumab lived a median of 11.5 months, Bloomberg reports.

Squamous non-small cell lung cancer accounts for 25 to 30 percent of all lung cancer, according to the American Cancer Society.

If necitumumab is approved, the drug could generate $567 million for Lilly by 2020, analysts tell Bloomberg.

Lilly already markets a lung cancer drug called Cyramza. The medication is approved for patients who have not had success with chemotherapy. Necitumumab would be used as an initial treatment with chemotherapy, according to Bloomberg.

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