FDA panel rebuffs Novartis' panobinostat

FDA's Oncologic Drugs Advisory Committee voted 5-2 that the progression-free survival (PFS) benefit of Farydak panobinostat ( LBH589) from Novartis AG (NYSE:NVS; SIX:NOVN) does not outweigh its 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 is under Priority Review.

Panel members said there is a clear PFS benefit with Farydak but were largely concerned about greater toxicity and a greater proportion of on-treatment deaths seen with the compound compared with placebo in the Phase III PANORAMA-1 trial (7% vs 3.5%). The members who voted "no" said Farydak does seem to have biological activity and said they hope Novartis continues to develop the compound, but felt the pharma needed to evaluate a different dose or combination. ...