Panobinostat (Farydak)

Note: this drug has been withdrawn from the US market but is still available in the EU and UK.
==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.Panobinostat (Farydak) package insertPanobinostat (Farydak) package insert, locally hosted backupNovartis's information about panobinostatHasegawa H, Yamada Y, Tsukasaki K, Mori N, Tsuruda K, Sasaki D, Usui T, Osaka A, Atogami S, Ishikawa C, Machijima Y, Sawada S, Hayashi T, Miyazaki Y, Kamihira S. LBH589, a deacetylase inhibitor, induces apoptosis in adult T-cell leukemia/lymphoma cells via activation of a novel RAIDD-caspase-2 pathway. Leukemia. 2011 Apr;25(4):575-87. Epub 2011 Jan 18. link to original article EuroPMCCrisanti MC, Wallace AF, Kapoor V, Vandermeers F, Dowling ML, Pereira LP, Coleman K, Campling BG, Fridlender ZG, Kao GD, Albelda SM. The HDAC inhibitor panobinostat (LBH589) inhibits mesothelioma and lung cancer cells in vitro and in vivo with particular efficacy for small cell lung cancer. Mol Cancer Ther. 2009 Aug;8(8):2221-31. Epub 2009 Aug 11. link to original article link to PMC article EuroPMC
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, or the prescribing information.
==Diseases for which it is used==
*Diffuse large B-cell lymphoma
*Multiple myeloma
==Diseases for which it was used==
*Acute myeloid leukemia
*Hodgkin lymphoma
*Peripheral T-cell lymphoma
*Waldenström macroglobulinemia
==Monitoring recommendations==
Panobinostant had 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 any longer than 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===
*2015-02-23: 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)
**2022-03-24: Accelerated approval for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent withdrawn at the request of the manufacturer. (No supporting studies are cited)
==History of changes in EMA indication==
*2015-08-28: Initial marketing authorization as Farydak.
*Uncertain date: 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.
==History of changes in PMDA indication==
*2015-07-03: Initial approval for the treatment of relapsed or refractory multiple myeloma.
==Also known as==
*Code name: LBH-589
*Generic name: panobinostat lactate anhydrous
*Brand names: Faridak, Farydak
==References==
Category:Drugs
Category:Oral medications
Category:HDAC inhibitors
Category:Diffuse large B-cell lymphoma medications
Category:Multiple myeloma medications
Category:Acute myeloid leukemia medications (historic)
Category:Classical Hodgkin lymphoma medications (historic)
Category:Peripheral T-cell lymphoma medications (historic)
Category:Waldenström macroglobulinemia medications (historic)
Category:REMS program
Category:EMA approved in 2015
Category:FDA approved in 2015
Category:FDA withdrawn in 2022
Category:EMA approved in 2015
Category:PMDA approved in 2015