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On November 30, 2021, it was announced that the U.S. Food and Drug Administration (FDA) will withdraw the approval of panobinostat for the treatment of patients with relapsed/refractory multiple myeloma (R/R MM).1
Panobinostat was first granted accelerated approval in combination with bortezomib and dexamethasone in February 2015 for patients who had previously received ≥2 prior regimens, including bortezomib and an immunomodulatory agent.2 The approval was based on the progression-free survival results from the phase III PANORAMA1 study (NCT01023308), which have previously been published on the Multiple Myeloma Hub. However, to maintain the approval, further adequate and well-controlled clinical studies were required to verify the clinical benefit of panobinostat. As it was not possible to complete these required post-approval clinical studies, the approval has been withdrawn.1
Panobinostat continues to be investigated in a phase II trial (NCT02506959) in combination with high-dose gemcitabine, busulfan, and melphalan prior to autologous stem cell transplantation in patients with R/R MM.3,4
NICE guidance on panobinostat for MM patients after at least two previous treatments
NICE have recommeded the use of panobinostat, in combination with bortezomib and dexamethasone, for the treatment of relapsed and refractory Multiple Myeloma.
Sub-group analysis of the PANORAMA-1 Trial: panobinostat plus bortezomib and dexamethasone by prior MM treatment
The addition of panobinostat to bortezomib plus dexamethasone led to a significant increase on PFS across all previous treatment groups.
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