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FDA Approved for RRMM: Panobinostat (Farydak) Capsules + Bortezomib (Velcade) and Dexamethasone
Updated: Oct 18, 2021
FDA Approved for RRMM: Panobinostat (Farydak) Capsules + Bortezomib(Velcade) and Dexamethasone
Relapsed & Refractory Multiple Myeloma
Basel, February 23, 2015 - Novartis announced today that the US Food and Drug Administration (FDA) 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 (IMiD) agent.
"Farydak represents an exciting agent with a new mechanism of action that is part of a promising class of drugs in this setting," said study investigator Paul Richardson, MD, Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute. "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."
Farydak has been shown to extend the progression-free survival (PFS) benefit of the standard-of-care therapy in this patient population. Farydak is approved under accelerated approval based on PFS. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The FDA's accelerated approval program gives patients access to treatments for serious or life-threatening illnesses that provide meaningful therapeutic benefit over existing treatments. The FDA has approved a risk evaluation and mitigation strategy (REMS) for Farydak. The REMS program serves to inform and educate healthcare professionals about the risks that may be associated with Farydak treatment.
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, randomized, double-blind, placebo-controlled, multicenter global registration trial, called PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA)
The trial found that the median PFS benefit increased in Farydak patients who had received prior treatment with both bortezomib and an IMiD (10.6 months; n=94), as compared to the placebo arm (5.8 months; n=99) (hazard ratio=0.52 [95% confidence interval (CI): 0.36, 0.76])
Feb/23/2015: Novartis receives FDA approval of Farydak®, the first HDAC inhibitor for patients with multiple myeloma
02/23/2015: FDA Approval