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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 As it was not possible to complete these required post-approval clinical studies, the approval has been withdrawn.1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. https://www.prnewswire.com/news-releases/secura-bio-announces-us-withdrawal-of-farydak--panobinostat-nda-301434428.html. Published Nov 30, 2021. Accessed Dec 2, 2021.
  2. U.S. Food and Drug Administration. Drug trials snapshot: FARYDAK (panobinostat). https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-farydak-panobinostat. Updated Jul 29, 2020. Accessed Dec 2, 2021.
  3. SecuraBio. Pipeline. https://securabio.com/pipeline. Accessed Dec 3, 2021.
  4. ClinicalTrials.gov. Panobinostat, gemcitabine hydrochloride, busulfan, and melphalan before stem cell transplant in treating patients with refractory or relapsed multiple myeloma. https://clinicaltrials.gov/ct2/show/NCT02506959. Updated Nov 22, 2021. Accessed Dec 3, 2021.

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