Panobinostat (Farydak)

Note: this drug has been withdrawn from the US market but is still available outside of the US.

General information

Class/mechanism: Pan-histone deacetylase (HDAC) inhibitor, or HDACi. Inhibition of histone deacetylases results in hyperacetylation of histones and modulates gene expression by creating an open chromatin state that leads to expression of previously silenced genes. This modulation has been observed to be associated with decreased expression of oncogenes such as Bcr-Abl and HER-2, induction of cell cycle arrest, promotion of apoptosis, and decreased invasion of tumor cells.
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Hodgkin lymphoma
• Multiple myeloma
• Peripheral T-cell lymphoma
• Waldenström macroglobulinemia

Diseases for which it was used

• Acute myeloid leukemia

Monitoring recommendations

Panobinostant has an informational REMS in place for severe diarrhea and cardiac toxicities.

• Refer to the Factsheet for detailed diarrhea management information.
• Per the REMS, do not start panobinostat if patient has any of the following:
  • Recent myocardial infarction
  • Unstable angina
  • QTcF ≥ 450 msec
  • Clinically significant ST-segment or T-wave abnormalities

Patient drug information

• Panobinostat (Farydak) package insert

History of changes in FDA indication

Multiple myeloma - WITHDRAWN

• 2/23/2015: FDA accelerated approval for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. (Based on PANORAMA 1)
  • 11/30/2021: Secura Bio submitted to FDA for the withdrawal of the approval of NDA 205353

History of changes in EMA indication

• 8/28/2015: Initial marketing authorization as Farydak.
• Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.

Also known as

• Code name: LBH589
• Generic name: panobinostat lactate anhydrous
• Brand names: Faridak, Farydak