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FDA approves Novartis’s multiple myeloma drug Farydak

The US Food and Drug Administration (FDA) has granted approval for Swiss drugmaker Novartis's Farydak (panobinostat) to treat patients with multiple myeloma.

Farydak is the first histone deacetylase (HDAC) inhibitor approved in combination with bortezomib, a type of chemotherapy, and dexamethasone, an anti-inflammatory medication, to treat patients who received at least two prior regimens including bortezomib and immunomodulatory (IMiD).

As an HDAC inhibitor, Farydak’s epigenetic activity may help to restore cell function in multiple myeloma.

Dana-Farber Cancer Institute Jerome Lipper Multiple Myeloma Centre director of Clinical Research 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."

The FDA granted accelerated approval for Farydak, as it showed to extend the progression-free survival (PFS) benefit of the standard-of-care therapy in this patient population.

The 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 randomized, double-blind, placebo-controlled, multicentre global registration Panorama-1 Phase III trial.

During the trial, participants were randomly assigned to receive a combination of Farydak, bortezomib and dexamethasone, or bortezomib and dexamethasone alone.

The trial showed 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.