Novartis' Farydak wins FDA approval for multiple myeloma
- After initially being told by the FDA that the risks of Farydak (panobinostat) did out outweigh the benefits for the treatment of multiple myeloma, Novartis has received an FDA approval for that indication—along with a black box warning.
- Farydak works by inhibiting histone deacetylases (HDACs), which is thought to slow the over-development of plasma cells in multiple myeloma patients.
- While the safety and efficacy of Farydak in combination with bortezomib and dexamethasone was demonstrated in 193 clinical trial subjects with multiple myeloma, there has been evidence of serious adverse events, which are included on the labeling. Adverse events include diarrhea and severe and fatal cardiac events, arrythmias, and ECG changes.
As the first FDA-approved HDAC inhibitor for the treatment of multiple myeloma, Farydak offers a new treatment option for combination use with standard co-therapies. Despite the addition of a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to physicians overviewing the risks, study results are compelling.
In clinical trials, Farydak-treated multiple myeloma patients saw a significant delay in disease progression (10.6 months of progression-free survival (PFS)), compared with patients treated with bortezemib and dexamethasone alone (5.8 months of PFS). Also, 59% of Farydak-treated patients experienced shrinkage of their cancer, compared with 41% of those receiving standard therapy.