Novartis Receives FDA Approval Of Farydak For Treatment Of Multiple Myeloma

(RTTNews) - Novartis AG (NVS) announced that the US Food and Drug Administration has approved Farydak (panobinostat, previously known as LBH589) 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 agent.

Novartis noted that this FDA approval is based on efficacy and safety data in a pre-specified subgroup analysis of 193 patients who had received prior treatment with both bortezomib and an IMiD during the Phase III trial, called PANORAMA-1. The trial found that the median PFS benefit increased in Farydak patients who had received prior treatment with both bortezomib and an IMiD, as compared to the placebo arm.

The company said Farydak is approved under FDA's accelerated approval program, while regulatory applications are underway in the EU, Japan and worldwide.

Multiple myeloma is a cancer of the plasma cells, a kind of white blood cell present in bone marrow-the soft, blood-producing tissue that fills the center of most bones.