ARTICLE | Clinical News

Farydak panobinostat regulatory update

November 10, 2014 8:00 AM UTC

FDA's Oncologic Drugs Advisory Committee voted 5-2 that the progression-free survival (PFS) benefit of Farydak panobinostat from Novartis does not outweigh its safety risks in combination with Velcade bortezomib and dexamethasone in multiple myeloma (MM) patients who have received >=1 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. ...