Oncologic Drugs Advisory Committee Meeting

Oncologic Drugs Advisory Committee Meeting Committee Meeting November 8, 2012 8:00 a.m. to 5:00 p.m Agenda: During the morning session, the committee will discuss new drug application (NDA) 204026, with the established name pomalidomide, application submitted by Celgene Corporation. The proposed indication (use) for this product is in combination with dexamethasone for patients with relapsed and refractory multiple myeloma who have received at least 2 prior regimens of established benefit, including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy. During the afternoon session, the committee will discuss supplemental New Drug Application (sNDA) 021882/015, with the trade name Exjade (deferasirox) tablets for oral suspension, application submitted by Novartis Pharmaceutical Corporation. The proposed indication (use) for this product is for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes (beta-thalassemia intermedia, HbE beta-thalassemia, and alpha-thalassemia) aged 10 years and older.