ARTICLE | Regulation

Panobinostat push back

Why ODAC didn't buy Novartis' explanation of panobinostat tox in MM Phase III

November 17, 2014 8:00 AM UTC

FDA's Oncologic Drugs Advisory Committee was unmoved by Novartis AG's argument that elevated rates of serious adverse events and on-treatment deaths seen in a global Phase III trial of panobinostat were the result of regional differences in side effect management and patient care, and that AEs and toxicity could be well managed in the U.S.

On Nov. 5, ODAC voted 5-2 that panobinostat's 3.9-month progression-free survival (PFS) benefit did not outweigh the safety risks of treating multiple myeloma (MM) in combination with Velcade bortezomib and dexamethasone...