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FDA Concern over Clot Risk for Eli Lilly Lung Cancer Drug

Jul 9, 2015

The Food and Drug Administration (FDA) is concerned that Eli Lilly & Co.'s experimental lung cancer drug may increase patients' risk of suffering potentially deadly blood clots.

The drug-necitumumab-improved patients' overall chances of survival, but people taking the drug also experienced greater clot risks, Food and Drug Administration staff reported this week. Lilly is seeking approval for necitumumab as a first-line treatment for a subset of the most common type of lung cancer, BloombergBusiness reports.

On July 9, an FDA advisory panel will meet to discuss the risks and benefits of necitumumab for patients with advanced squamous non-small cell lung cancer (NSCLC), in combination with chemotherapy. The American Cancer Society says that squamous lung cancer accounts for 25 percent to 30 percent of all lung cancer cases. The FDA's decision about whether Lilly can market the drug is expected by the end of the year, according to BloombergBusiness. According to the briefing document, the FDA's "final determination may be affected by issues not discussed at the advisory committee meeting." Industry analysts estimate that if approved, necitumumab would generate $567 million in sales in 2020.

The FDA report said necitumumab's safety is consistent with that of similar drugs, but the agency's briefing document expressed concern about the increased danger of clotting "in this already high risk population." According to the FDA, "The key issue for this application is the balance of benefit versus risk." In one study, out of 538 patients taking necitumumab and chemotherapy, 9 percent experienced a serious clot, compared with 5 percent of 541 patients given only chemotherapy, according to the FDA. Patients in a clinical trial who took necitumumab lived a median of 11.5 months, which is 1.6 months longer than those who received only chemotherapy, the FDA staff report said.

Lilly already sells the drug Cyramza (ramucirumab), a treatment for non-small cell lung cancer approved for patients who have tried chemotherapy and their cancer still progressed. Necitumumab would be used as an initial treatment with chemotherapy.

Other treatments for non-small cell lung cancer include Roche Holding AG's Avastin (bevacizumab) and Bristol-Myers Squibb Co.'s Opdivo (nivolumab). Opdivo was approved in March of this year to treat lung cancer in patients who have already had chemotherapy. In a clinical trial, patients who took Opdivo lived an average, 3.2 months longer than those who received chemotherapy only, according to BloombergBusiness.

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