Accelerated Approval Withdrawn for Farydak

Viewing 0 reply threads
  • Author
    Posts
    • #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.

Viewing 0 reply threads

You must be logged in to reply to this topic.

Accelerated Approval Withdrawn for Farydak
This website uses cookies to improve your experience. By using this website you agree to our Cookie Policy.
Read more