FDA Approves Novartis’ Cancer Drug FarydakBy
Novartis reports that the US Food and Drug Administration (FDA) has approved Farydak (panobinostat) capsules in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory (IMiD) agent.
Farydak works by inhibiting the activity of enzymes, known as histone deacetylases (HDACs). This process may slow the over-development of plasma cells in multiple myeloma patients or cause these dangerous cells to die. Farydak is the first HDAC inhibitor for treating multiple myeloma. As an HDAC inhibitor, its epigenetic activity may help to restore cell function in multiple myeloma. Epigenetics is the cell programming that governs gene expression and cell development. In multiple myeloma, the normal epigenetic process is disrupted (also called epigenetic dysregulation) resulting in the growth of cancerous plasma cells, potential resistance to current treatment, and ultimately disease progression.
Additional regulatory submissions for Farydak are being reviewed by health authorities worldwide.
The FDA granted Farydak priority review and orphan product designation. Priority review provides for an expedited review of drugs that are intended to treat a serious disease or condition and may provide a significant improvement over available therapy. Orphan product designation is given to drugs intended to treat rare diseases.