FDA refuses to recommend semuloparin (Sanofi) for prevention of VTE

The FDA's Oncologic Drugs Advisory Committee voted 14 to 1 not to recommend approval of semuloparin, from Sanofi, for the prevention of Venous Thromboembolism (VTE) in patients receiving chemotherapy for metastatic Lung or Pancreatic Cancer. The committee also rejected its use in patients with advanced solid tumours with a VTE risk score greater than or equal to three. The submission is based on the SAVE-ONCO trial of 3,212 patients which showed that 1.2% of patients receiving semuloparin had a VTE or related death, compared to 3.4% on placebo. Semuloparin is seen as a successor to Lovenox (enoxaparin).