MedPath

Panobinostat

Generic Name
Panobinostat
Brand Names
Farydak
Drug Type
Small Molecule
Chemical Formula
C21H23N3O2
CAS Number
404950-80-7
Unique Ingredient Identifier
9647FM7Y3Z

Overview

Panobinostat is an oral deacetylace (DAC) inhibitor approved on February 23, 2015 by the FDA for the treatment of multiple myeloma. The approval was accelerated based on progression-free survival, therefore confirmatory trials by the sponsor to demonstrate clinical efficacy in multiple myeloma treatment are in progress of being conducted. Panobinostat is marketed by Novartis under the brand name Farydak. Panobinostat acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor) and it is the most potent DAC inhibiting agent available on the market.

Background

Panobinostat is an oral deacetylace (DAC) inhibitor approved on February 23, 2015 by the FDA for the treatment of multiple myeloma. The approval was accelerated based on progression-free survival, therefore confirmatory trials by the sponsor to demonstrate clinical efficacy in multiple myeloma treatment are in progress of being conducted. Panobinostat is marketed by Novartis under the brand name Farydak. Panobinostat acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor) and it is the most potent DAC inhibiting agent available on the market.

Indication

Panobinostat is indicated in the treatment of multiple myeloma in combination with dexamethasone and bortezomib in patients who have received 2 previous treatment regimens including bortezomib and an immunomodulatory agent. This indication is approved by accelerated approval based on progression free survival as of February 23, 2015.

Associated Conditions

  • Refractory Multiple Myeloma

FDA Approved Products

FARYDAK
Manufacturer:Secura Bio, Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2021/07/27
NDC:73116-100
FARYDAK
Manufacturer:Secura Bio, Inc.
Route:ORAL
Strength:20 mg in 1 1
Approved: 2021/07/27
NDC:73116-102
FARYDAK
Manufacturer:Secura Bio, Inc.
Route:ORAL
Strength:15 mg in 1 1
Approved: 2021/07/27
NDC:73116-101

Singapore Approved Products

No Singapore products found for this drug

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