Farydak FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 7, 2021.
Farydak (panobinostat) is a histone deacetylase inhibitor for use in combination with bortezomib and dexamethasone to treat patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent.
- The accelerated approval granted to Farydak in 2015 was based on progression-free survival requiring further adequate and well-controlled post-approval clinical studies to verify and describe the product's clinical benefit.
- On November 30, 2021, Secura Bio announced the withdrawal of Farydak. The required post-approval studies had not been completed and the clinical benefits of Farydak could not be confirmed under the specific constraints of the accelerated approval process.
Development timeline for Farydak
|Nov 30, 2021||Secura Bio Announces U.S. Withdrawal of Farydak (panobinostat) NDA|
|Feb 23, 2015||Approval FDA Approves Farydak (panobinostat) for Multiple Myeloma|
|Nov 6, 2014||Novartis Announces Outcome of FDA Advisory Committee Meeting for LBH589 (Panobinostat)|
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