Accelerated Approval Withdrawn for Farydak

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    • #48615
      TDP
      Keymaster

      Secura Bio has submitted to the FDA for the withdrawal of the approval of Farydak (panobinostat) in the US for use in combination with bortezomib and dexamethasone to treat patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. Secura Bio noted in its withdrawal submission that it was not feasible for the company to complete the required postapproval clinical studies as designed as part of the accelerated approval process.

      Further information may be found at https://www.prnewswire.com/news-releases/secura-bio-announces-us-withdrawal-of-farydak–panobinostat-nda-301434428.html.

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