Farydak

panobinostat

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This is a summary of the European public assessment report (EPAR) for Farydak. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Farydak.

For practical information about using Farydak, patients should read the package leaflet or contact their doctor or pharmacist.

What is Farydak and what is it used for?

Farydak is a cancer medicine used in combination with two other medicines, bortezomib and dexamethasone, to treat multiple myeloma (a cancer of the bone marrow). It is given to adults whose disease has come back or got worse after at least two previous treatments, including bortezomib and an immunomodulatory medicine (a medicine that acts on the immune system).

Farydak contains the active substance panobinostat.

Because the number of patients with multiple myeloma is low, the disease is considered ‘rare’, and Farydak was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 November 2012.

How is Farydak used?

Treatment with Farydak must be started by a doctor experienced in the treatment of cancer and the medicine can only be obtained with a prescription.

Farydak is available as capsules (10, 15 and 20 mg) and it is given in 21-day treatment cycles, together with bortezomib and dexamethasone. The recommended starting dose of Farydak is 20 mg, taken on days 1, 3, 5, 8, 10 and 12 of the cycle. Patients are given the medicine for 8 cycles, and further 8 cycles of treatment are recommended in those that benefit. The doctor may have to adjust or delay the dose in patients who experience severe side effects. For further information, see the summary of product characteristics (part of the product information).

How does Farydak work?

The active substance in Farydak, panobinostat, is a type of medicine called a histone deacetylase (HDAC) inhibitor. It blocks the activity of enzymes called histone deacetylases (HDACs), which are involved in switching the activity of genes on and off within cells. In multiple myeloma, panobinostat is expected to keep genes that suppress the division and growth of the cancer cells switched ‘on’. This is expected to stop the cancer cells from multiplying and to activate processes that kill the cell, thereby slowing down the growth of the cancer.

What benefits of Farydak have been shown in studies?

The benefits of Farydak have been shown in one main study involving 768 patients with multiple myeloma that had come back after previous treatments. The medicine was compared with placebo (a dummy treatment) as an addition to treatment with bortezomib and dexamethasone. The main measure of effectiveness was the average length of time before the patient’s disease got worse again (progression-free survival), which was 12 months in patients given Farydak, compared with around 8 months in those given placebo.

When results were analysed just for the group of patients who had previously received at least two previous treatments, including bortezomib and an immunomodulatory medicine (thalidomide, lenalidomide or pomalidomide), the average time until the myeloma got worse was 12.5 months with Farydak, versus 4.7 months with placebo.

What are the risks associated with Farydak?

The most common side effects with Farydak (which may affect more than 1 in 10 people) are diarrhoea, tiredness, nausea (feeling sick) and vomiting, and effects on the blood such as thrombocytopenia (low levels of blood platelets which are important for blood clotting), anaemia and neutropenia and lymphopenia (low levels of certain white blood cells). The most significant effects that led to patients having to stop treatment (which happened in about 4 patients in 10) were diarrhoea, weakness and tiredness, and pneumonia (lung infection). Effects on the heart occurred in between 1 and 2 patients in 10 and included tachycardia (increased heart rate), palpitations, and irregular heart rhythms (atrial fibrillation, sinus tachycardia); more rarely patients had changes in electrical conduction in the heart (prolonged QTc interval). For the full list of all side effects reported with Farydak, see the package leaflet.

Farydak must not be used in women who are breast-feeding. For the full list of restrictions, see the package leaflet.

Why is Farydak approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) considered the increase in progression free survival to be clinically significant although it noted that a benefit in overall survival had not yet been shown. In addition, panobinostat works in a different way to existing treatments. This means that for patients who have previously received at least two previous treatments, including bortezomib and immunomodulatory agents, who have limited treatment options and therefore a high unmet medical need, it offers a new alternative. Although the side effects were of concern and could not be justified in patients who could be given less toxic treatments, the CHMP considered that they were acceptable in this previously treated subgroup in view of the lack of alternatives, and could be managed. The CHMP therefore decided that Farydak’s benefits are greater than its risks in this group and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Farydak?

A risk management plan has been developed to ensure that Farydak is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Farydak, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Farydak will provide educational materials for patients, including a patient card, to help them take the medicine correctly. It will also provide a final analysis from the main study on how long patients who have been treated with the medicine survive.

Further information can be found in the summary of the risk management plan.

Other information about Farydak

The European Commission granted a marketing authorisation valid throughout the European Union for Farydak on 28 August 2015.

For more information about treatment with Farydak, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Farydak : EPAR - Summary for the public BG = bălgarski 11/09/2015  
Farydak : EPAR - Summary for the public ES = español 11/09/2015  
Farydak : EPAR - Summary for the public CS = čeština 11/09/2015  
Farydak : EPAR - Summary for the public DA = dansk 11/09/2015  
Farydak : EPAR - Summary for the public DE = Deutsch 11/09/2015  
Farydak : EPAR - Summary for the public ET = eesti keel 11/09/2015  
Farydak : EPAR - Summary for the public EL = elliniká 11/09/2015  
Farydak : EPAR - Summary for the public EN = English 11/09/2015  
Farydak : EPAR - Summary for the public FR = français 11/09/2015  
Farydak : EPAR - Summary for the public IT = italiano 11/09/2015  
Farydak : EPAR - Summary for the public LV = latviešu valoda 11/09/2015  
Farydak : EPAR - Summary for the public LT = lietuvių kalba 11/09/2015  
Farydak : EPAR - Summary for the public HU = magyar 11/09/2015  
Farydak : EPAR - Summary for the public MT = Malti 11/09/2015  
Farydak : EPAR - Summary for the public NL = Nederlands 11/09/2015  
Farydak : EPAR - Summary for the public PL = polski 11/09/2015  
Farydak : EPAR - Summary for the public PT = português 11/09/2015  
Farydak : EPAR - Summary for the public RO = română 11/09/2015  
Farydak : EPAR - Summary for the public SK = slovenčina 11/09/2015  
Farydak : EPAR - Summary for the public SL = slovenščina 11/09/2015  
Farydak : EPAR - Summary for the public FI = suomi 11/09/2015  
Farydak : EPAR - Summary for the public SV = svenska 11/09/2015  
Farydak : EPAR - Summary for the public HR = Hrvatski 11/09/2015  
Name Language First published Last updated
Farydak : EPAR - Risk-management-plan summary (English only) 11/09/2015  

This EPAR was last updated on 13/04/2016 .

Authorisation details

Product details

Product details for Farydak
NameFarydak
Agency product numberEMEA/H/C/003725
Active substance

panobinostat lactate anhydrous

International non-proprietary name (INN) or common name

panobinostat

Therapeutic area Multiple Myeloma
Anatomical therapeutic chemical (ATC) code L01XX42
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Farydak
Marketing-authorisation holder

Novartis Europharm Ltd

Revision1
Date of issue of marketing authorisation valid throughout the European Union28/08/2015

Contact address:

Novartis Europharm Ltd
Frimley Business Park 
Camberley GU16 7SR 
United Kingdom

Product information

Product information

25/02/2016  Farydak -EMEA/H/C/003725 -II/0003

Name Language First published Last updated
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016
Farydak : EPAR - Product Information EN = English 11/09/2015 13/04/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  
Farydak : EPAR - All Authorised presentations EN = English 11/09/2015  

Pharmacotherapeutic group

Other antineoplastic agents

Therapeutic indication

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Farydak : EPAR - Procedural steps taken and scientific information after authorisation EN = English 13/04/2016  

Initial marketing-authorisation documents

Name Language First published Last updated
Farydak : EPAR - Public assessment report EN = English 11/09/2015  
CHMP summary of positive opinion for Farydak EN = English 26/06/2015  

Authorised

This medicine is approved for use in the European Union

Related information

Preventing medication errors