FDA asks if panobinostat's PFS benefit outweighs risks

FDA is asking its Oncologic Drugs Advisory Committee whether the progression-free survival (PFS) benefit of Farydak panobinostat ( LBH589) from Novartis AG (NYSE:NVS; SIX:NOVN) outweighs safety risks in combination with Velcade bortezomib and dexamethasone in multiple myeloma patients who have received at least one prior therapy. An NDA for the oral pan-deacetylase (DAC) inhibitor based on data from a single, double-blind Phase III trial is under Priority Review.

In the 768-patient PANORAMA-1 trial, Farydak plus Velcade and dexamethasone led to a 3.9-month improvement in median PFS -- the primary endpoint -- as assessed by investigators compared with placebo plus Velcade and dexamethasone (12 vs. 8.1 months, p<0.0001). ...