# Panobinostat

Panobinostat (Farydak, pharmaand GmbH) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Multiple myeloma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + bortezomib and dexamethasone | 3rd line+ | After at least two prior regimens including bortezomib and an immunomodulatory agent |

## Products

### Farydak

- Company: pharmaand GmbH
- Target: Histone deacetylase (HDAC) inhibitor
- Class: Histone deacetylase (HDAC) inhibitors
- ATC: L01XH03
- EU approval: 28 Aug 2015
- Label revised: 1 Oct 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/farydak-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/farydak-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/farydak

Mechanism (SmPC section 5.1): Inhibits HDAC enzymatic activity, increasing acetylation of histones and other proteins, relaxing chromatin and inducing cell cycle arrest and/or apoptosis of transformed cells.

## Label wording

- **Panobinostat** (Farydak), Multiple myeloma, 3rd line+: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/farydak-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/panobinostat