FDA withdrawal of panobinostat for the treatment of R/R MM

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 As it was not possible to complete these required post-approval clinical studies, the approval has been withdrawn.¹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