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FDA committee rejects experimental blood clot drug
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The FDA’s Oncologic Drugs Advisory Committee today overwhelmingly rejected an experimental drug intended to prevent blood clots in patients with cancer.
Sanofi SA sought approval for semuloparin injection for use in patients with cancer who are undergoing chemotherapy, arguing that the drug could reduce patients’ risk for developing venous thromboembolism.
The advisory committee rejected the request by a 14-1 vote, contending Sanofi SA failed to clearly identify which patients would benefit from the drug.
The FDA often follows the advisory committee’s recommendations, but it is not obligated to do so.
In a Sanofi-funded study designed to investigate the efficacy of semuloparin injection, researchers enrolled more than 3,000 patients undergoing chemotherapy for a variety of cancers.
The researchers assigned 1,608 patients to semuloparin and 1,604 patients to placebo.
According to study results, published earlier this year in The New England Journal of Medicine, VTE occurred in 20 (1.2%) of the patients who received semuloparin vs. 55 (3.4%) of the patients who received the placebo (HR=0.36; 95% CI, 0.21-0.60).
The researchers concluded that the drug was effective and reduced the incidence of VTE in patients undergoing chemotherapy for cancer.
The FDA advisory committee, however, questioned the drug’s clinical value, noting that most patients evaluated in clinical trials died of problems other than clotting.
In the Sanofi-funded study, for example, 3.4% of patients assigned to placebo experienced VTE, but 5% of patients died of other causes.
The FDA panel also pointed to the high number of bleeding-related events that occurred in patients treated with semuloparin, including one death from bleeding in the brain. The incidence of clinically relevant bleeding was 2.8% in the semuloparin arm vs. 2% in the placebo group (HR=1.40; 95% CI, 0.89-2.21), according to study results. Major bleeding occurred in 19 (1.2%) of patients who received semuloparin vs. 18 (1.1%) of patients assigned to the placebo (HR=1.05; 95% CI, 0.55-1.99).
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