Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee
Committee Meeting June 20, 2012 8:00 a.m. to 5:00 p.m

Agenda: During the morning session, the committee will discuss New Drug Application (NDA) 203213, with the established name semuloparin sodium injection, application submitted by sanofi-aventis U.S. LLC. The proposed indication (use) for this product is for the prophylaxis of venous thromboembolism (VTE) in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors with a VTE risk score ≥ 3.

During the afternoon session, the committee will discuss New Drug Application (NDA) 202714, with the proposed trade name Kyprolis (carfilzomib) for injection, application submitted by Onyx Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of patients with relapsed and refractory (recurring and/or not responsive to other treatments) multiple myeloma who have received at least 2 prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent.