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

Dec 5, 2021

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 As it was not possible to complete these required post-approval clinical studies, the approval has been withdrawn.1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

  1. Cision PR Newswire. Secura Bio announces U.S. withdrawal of FARYDAK ® (panobinostat) NDA. Published Nov 30, 2021. Accessed Dec 2, 2021.
  2. U.S. Food and Drug Administration. Drug trials snapshot: FARYDAK (panobinostat). Updated Jul 29, 2020. Accessed Dec 2, 2021.
  3. SecuraBio. Pipeline. Accessed Dec 3, 2021.
  4. Panobinostat, gemcitabine hydrochloride, busulfan, and melphalan before stem cell transplant in treating patients with refractory or relapsed multiple myeloma. Updated Nov 22, 2021. Accessed Dec 3, 2021.


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