Novartis announced today that the European Commission has approved Farydak ® (panobinostat, previously known as LBH589) capsules, in combination with bortezomib* and dexamethasone, 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 (IMiD).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Farydak® (panobinostat, previously known as LBH589) capsules, in combination with bortezomib[*] and dexamethasone, 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 (IMiD).
Panobinostat combination more than doubled median PFS benefit by 7.8 months in patients who received >=2 prior lines of therapy, including bortezomib and IMiD[1]
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Field
Value
Cited text
Known as
Panobinostat
“In this randomized phase 2 study, we evaluated the response rate and toxicity of panobinostat, a pan-HDI administered 30 mg orally 3 times weekly, with or without rituximab, in...” PMID 27166360 ↗May 2016109
“The purpose of this Phase I study is to find the maximum tolerated dose of MTX110 (a water-soluble Panobinostat nanoparticle formulation) and Gadolinium that can be given...” NCT04264143 ↗
“Panobinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer...” NCT01440582 ↗
“This study comprises of a dose-escalation and dose expansion phase and will determine the maximum tolerated dose of oral Panobinostat on a continuous schedule in adult in...” NCT00532389 ↗
“A phase II non-randomized single arm trial of oral panobinostat (LBH589) was conducted in patients with low or intermediate-1 risk myelodysplastic syndrome (MDS).” PMID 22072492 ↗Nov 2011
“Enrolled patients will receive 4 infusions per week of panobinostat (MTX110; 0.25 ml of 300 μM = 26.2 μg), per infusion into the ventricular access device” NCT04315064 ↗
“Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds.” NCT01007968 ↗
“LBH589 (Panobinostat) is a new pill that works by blocking a special group of proteins called histone deacetylases (HDACs).” NCT01055795 ↗
“i.v. and Oral Panobinostat (LBH589) in Combination With i.v. Trastuzumab (Herceptin®) and i.v. Paclitaxel” NCT00788931 ↗
“An Expanded Treatment Protocol of Panobinostat (LBH589) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma Who Have Had at Least One Prior Line...” NCT02204553 ↗60
“A Phase I Study of LBH589 (Panobinostat) in Combination With External Beam Radiotherapy for the Treatment of Prostate Cancer, Esophageal Cancer and Head and Neck Cancer” NCT00670553 ↗
“This summary will use Panobinostat (LBH589) in patients with neuroendocrine tumors to see how the patient's tumor responds to panobinostat.” NCT00985946 ↗
“Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds.” NCT00997399 ↗
“Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds.” NCT01007968 ↗
“Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.” NCT02290431 ↗
“i.v. and Oral Panobinostat (LBH589) in Combination With i.v. Trastuzumab (Herceptin®) and i.v. Paclitaxel” NCT00788931 ↗
“A Phase I Trial of Panobinostat (LBH589) and Epirubicin in Patients With Solid Tumor Malignancies” NCT00878904 ↗
“A Phase IB Study of the Histone Deacetylase Inhibitor Panobinostat (LBH589) Given Orally” NCT01159418 ↗
“Each patient will receive panobinostat (LBH589) and letrozole.” NCT01105312 ↗
“The purpose of this Phase I study is to find the maximum tolerated dose of MTX110 (a water-soluble Panobinostat nanoparticle formulation) and Gadolinium that can be given...” NCT04264143 ↗2
“Enrolled patients will receive 4 infusions per week of panobinostat (MTX110; 0.25 ml of 300 μM = 26.2 μg), per infusion into the ventricular access device” NCT04315064 ↗
“DESIGN: Here we evaluate the impact of in-vivo administration of vorinostat (VOR) and panobinostat (PNB) during clinical trials on natural killer (NK) cell function and phenotype.” PMID 30830886 ↗Mar 2019
Action
Inhibit
“Panobinostat is a potent, oral pan-deacetylase inhibitor (pan-DACi) that increases the acetylation of proteins involved in multiple oncogenic pathways.” PMID 22981498 ↗Sep 2012
Modality
Small molecule
“Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds.” NCT00997399 ↗