Last week the FDA announced the approval of Novartis’ Farydak (panibinostat) for multiple myeloma. The drug was approved in combination with bortezomib and dexamethasone in patients who have been previously been treated with bortezomib and an immunomodulatory agent (IMiD) (and received at least two prior regimens).
Farydak was approved based on an interim subgroup analysis of the phase III PANORAMA trial which showed a significant improvement in progression-free survival compared with placebo. Continued availability in the US may be contingent upon confirmatory trials.
Farydak is the first histone deacetylase (HDAC) inhibitor in multiple myeloma. Deacetylases are enzymes which remove the small molecule acetyl from cell proteins. This allows for protein production, cell reproduction and elimination of waste proteins. By blocking this process, HDAC inhibitors kill cells by causing waste proteins to build up.