Briefing Summary: US FDA Posts Advisory Committee Materials for Novartis’ Panobinostat for Multiple Myeloma and Rockwell Medical’s Triferic to Maintain Hemoglobin Levels in Patients with Kidney Disease While Reducing the ESA Needed – NOV 6, 2014 (ODAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Thursday, November 6, 2014 Oncologic Drugs Advisory Committee (ODAC) meeting.
During the morning session, the committee will discuss new drug application (NDA) 205353, panobinostat capsules, submitted by Novartis Pharmaceuticals Corporation. The proposed indication for this product is in combination with bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
During the afternoon session, the committee will discuss NDA 206317, ferric pyrophosphate solution, for administration via hemodialysis dialysate, submitted by Rockwell Medical, Inc. The proposed indication for this product is for the treatment of iron loss or iron deficiency to maintain hemoglobin (Hgb) in adult patients with hemodialysis-dependent stage 5 chronic kidney disease and to reduce the prescribed dose of erythropoiesis stimulating agent (ESA) required to maintain desired hemoglobin levels.