Semuloparin for the prevention of venous thromboembolic events in cancer patients.

Cancer-associated venous thromboembolism increases the morbidity and mortality in patients with cancer, being the second leading cause of death among these patients. As such, it has important clinical and economical consequences and current guidelines recommend thromboprophylaxis for cancer patients who are admitted to the hospital for medical illness or for major cancer surgery but not for routine use in ambulatory patients receiving chemotherapy. Semuloparin (AVE-5026) is a hemisynthetic, ultra-low-molecular-weight heparin, with high anti-factor Xa and residual antithrombin activities that was submitted for approval to the European Medicines Agency and the U.S. Food and Drug Administration in September 2011 for the prevention of venous thromboembolism in cancer patients. In a multicenter trial (SAVE-ONCO), once-daily, subcutaneous semuloparin at 20 mg administered to 1,608 patients receiving chemotherapy for locally advanced or metastatic solid tumors significantly prevented venous thromboembolism without increasing major bleeding, suggesting that semuloparin thrombo-prophylaxis can be beneficial in cancer patients receiving chemotherapy.