ODAC votes against semuloparin

FDA's Oncologic Drugs Advisory Committee voted 14-1, with one abstention, against recommending approval of semuloparin from Sanofi (Euronext:SAN; NYSE:SNY) for thromboprophylaxis in cancer patients. Sanofi is seeking approval of the ultra-low molecular weight heparin to prevent venous thromboemoblism (VTE) in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer, or for locally advanced or metastatic solid tumors at high risk of VTE. In briefing documents released ahead of the meeting, FDA reviewers said the efficacy of semuloparin in the indication appears to be "small" relative to the overall mortality in cancer patients receiving chemotherapy (see BioCentury Extra, June 18). ...