Difference between revisions of "Panobinostat (Farydak)"

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m (Text replacement - "[[Category:Hodgkin lymphoma " to "[[Category:Classical Hodgkin lymphoma ")
 
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==Diseases for which it is used==
 
==Diseases for which it is used==
 +
*[[Diffuse large B-cell lymphoma]]
 
*[[Multiple myeloma]]
 
*[[Multiple myeloma]]
  
 
==Diseases for which it was used==
 
==Diseases for which it was used==
 
*[[Acute myeloid leukemia - historical|Acute myeloid leukemia]]
 
*[[Acute myeloid leukemia - historical|Acute myeloid leukemia]]
−
*[[Hodgkin lymphoma - historical|Hodgkin lymphoma]]
+
*[[Classical Hodgkin lymphoma - historical|Hodgkin lymphoma]]
 
*[[Peripheral T-cell lymphoma - historical|Peripheral T-cell lymphoma]]
 
*[[Peripheral T-cell lymphoma - historical|Peripheral T-cell lymphoma]]
 
*[[Waldenström macroglobulinemia - historical|Waldenström macroglobulinemia]]
 
*[[Waldenström macroglobulinemia - historical|Waldenström macroglobulinemia]]
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**Recent myocardial infarction
 
**Recent myocardial infarction
 
**Unstable angina
 
**Unstable angina
−
**QTcF ≥ 450 msec
+
**QTcF any longer than 450 msec
 
**Clinically significant ST-segment or T-wave abnormalities
 
**Clinically significant ST-segment or T-wave abnormalities
  
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===[[Multiple myeloma]] - '''WITHDRAWN'''===
 
===[[Multiple myeloma]] - '''WITHDRAWN'''===
 
*2015-02-23: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435296.htm FDA accelerated approval] for the treatment of patients with [[Multiple myeloma|multiple myeloma]] who have received at least 2 prior regimens, including [[Bortezomib (Velcade)|bortezomib]] and an [[:Category:Immunomodulatory_drugs_(IMiDs)|immunomodulatory agent]]. ''(Based on PANORAMA 1)''
 
*2015-02-23: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435296.htm FDA accelerated approval] for the treatment of patients with [[Multiple myeloma|multiple myeloma]] who have received at least 2 prior regimens, including [[Bortezomib (Velcade)|bortezomib]] and an [[:Category:Immunomodulatory_drugs_(IMiDs)|immunomodulatory agent]]. ''(Based on PANORAMA 1)''
−
**2022-03-24: Approval for the treatment of patients with [[Multiple myeloma|multiple myeloma]] who have received at least 2 prior regimens, including [[Bortezomib (Velcade)|bortezomib]] and an [[:Category:Immunomodulatory_drugs_(IMiDs)|immunomodulatory agent]] withdrawn at the request of the manufacturer. ''(No supporting studies are cited)''
+
**2022-03-24: Accelerated approval for the treatment of patients with [[Multiple myeloma|multiple myeloma]] who have received at least 2 prior regimens, including [[Bortezomib (Velcade)|bortezomib]] and an [[:Category:Immunomodulatory_drugs_(IMiDs)|immunomodulatory agent]] withdrawn at the request of the manufacturer. ''(No supporting studies are cited)''
  
 
==History of changes in EMA indication==
 
==History of changes in EMA indication==
 
*2015-08-28: Initial marketing authorization as Farydak.
 
*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 [[Multiple myeloma, relapsed-refractory|relapsed and/or refractory multiple myeloma]] who have received at least two prior regimens including bortezomib and an immunomodulatory agent.
+
*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==
 
==Also known as==
−
*'''Code name:''' LBH589
+
*'''Code name:''' LBH-589
 
*'''Generic name:''' panobinostat lactate anhydrous
 
*'''Generic name:''' panobinostat lactate anhydrous
 
*'''Brand names:''' Faridak, Farydak
 
*'''Brand names:''' Faridak, Farydak
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[[Category:HDAC inhibitors]]
 
[[Category:HDAC inhibitors]]
  
 +
[[Category:Diffuse large B-cell lymphoma medications]]
 
[[Category:Multiple myeloma medications]]
 
[[Category:Multiple myeloma medications]]
  
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[[Category:FDA withdrawn in 2022]]
 
[[Category:FDA withdrawn in 2022]]
−
[[Category:EMA approved drugs]]
+
[[Category:EMA approved in 2015]]
−
[[Category:PMDA approved drugs]]
+
[[Category:PMDA approved in 2015]]

Latest revision as of 11:44, 9 April 2024

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.[1][2][3][4][5]
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.[1]

Diseases for which it is used

Diseases for which it was used

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

History of changes in FDA indication

Multiple myeloma - WITHDRAWN

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

  1. ↑ 1.0 1.1 1.2 Panobinostat (Farydak) package insert
  2. ↑ Panobinostat (Farydak) package insert, locally hosted backup
  3. ↑ Novartis's information about panobinostat
  4. ↑ Hasegawa 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 PubMed
  5. ↑ Crisanti 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 PubMed
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