Novartis has received approval from the US Food and Drug Administration (FDA) for its Farydak (panobinostat or earlier known as LBH589) capsules in combination with bortezomib and dexamethasone to treat patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory (IMiD) agent.
Farydak obtained FDA accelerated approval, as it demonstrated to extend the progression-free survival (PFS) benefit of the standard-of-care therapy in this patient population.
According to Novartis, Farydak is the first histone deacetylase (HDAC) inhibitor for patients with multiple myeloma.
Dana-Farber Cancer Institute Jerome Lipper Multiple Myeloma Centre clinical research director and study investigator Paul Richardson said: "Importantly, Farydak has been shown to improve progression-free survival in relapsed multiple myeloma patients who have received at least two prior regimens, including bortezomib and an IMiD, which is an area of particular unmet medical need."
Approval was 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, randomised, double-blind, placebo-controlled, multicentre global registration trial, Panorama-1 (PANobinostat ORAl in Multiple MyelomA).
The study demonstrated 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.
Novartis Oncology president Bruno Strigini said: "Novartis is committed to developing innovative first-in-class therapies for patients who need treatment options.
"Farydak represents a new drug class in multiple myeloma, providing these patients with an important treatment approach for this difficult-to-treat cancer."
Image: Histopathological image of multiple myoloma. Photo: courtesy of KGH.