Human medicines European public assessment report (EPAR): Zolsketil pegylated liposomal, doxorubicin, Date of authorisation: 31/05/2022, Revision: 5, Status: Authorised

• Application under evaluation
• CHMP opinion
• European Commission decision

Overview

Zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:

• breast cancer that has spread to other parts of the body in patients at risk of heart problems. Zolsketil pegylated liposomal is used on its own for this disease;

• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;

• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. Zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);

• Kaposi’s sarcoma in patients with AIDS who have a very damaged immune system. Kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs.

Zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance called Adriamycin. However, in Zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for Adriamycin.

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How is Zolsketil pegylated liposomal used?

Zolsketil pegylated liposomal can only be obtained with a prescription. It should only be given under the supervision of a cancer doctor who is specialised in the use of cytotoxic (cell-killing) medicines. It cannot be interchanged with other medicines that contain doxorubicin.

Zolsketil pegylated liposomal is given by infusion (drip) into a vein. The dose depends on the condition it is used for and is calculated on the basis of the patient’s weight and height. The doctor may stop treatment or reduce the dose if certain side effects occur or if the patient has liver problems.

For more information about using Zolsketil pegylated liposomal, see the package leaflet or contact your doctor or pharmacist.

How does Zolsketil pegylated liposomal work?

Doxorubicin, the active substance in Zolsketil pegylated liposomal, is a cytotoxic medicine that belongs to the group ‘anthracyclines’. It interferes with the DNA in cancer cells, preventing them from making more copies of DNA. This means that cancer cells cannot divide and eventually die. Zolsketil pegylated liposomal builds up in areas in the body where the blood vessels have an abnormal shape, such as within tumours, where its action is concentrated.

Doxorubicin has been available since the 1960s. In Zolsketil pegylated liposomal, it is enclosed in ‘pegylated liposomes’ (tiny fat particles coated with a substance called polyethylene glycol). This slows down removal of the medicine, allowing it to circulate in the blood for longer. It also reduces its effects on healthy tissues and cells, so it is less likely to cause specific side effects.

What benefits of Zolsketil pegylated liposomal have been shown in studies?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Adriamycin, and do not all need to be repeated for Zolsketil pegylated liposomal. However, since Adriamycin contains doxorubicin in a different form (not enclosed in pegylated liposomes), the company also presented results from a study in patients with ovarian cancer to show that Zolsketil pegylated liposomal is bioequivalent to Caelyx, another authorised medicine that contains doxorubicin in pegylated liposomal form.

Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the risks associated with Zolsketil pegylated liposomal?

The most common side effects with Zolsketil pegylated liposomal (which may affect more than 1 in 5 people) are neutropenia (low levels of neutrophils, a type of white blood cell), nausea (feeling sick), leukopenia (low levels of leukocytes, a type of white blood cell), anaemia (low levels of red blood cells), and tiredness.

The most common serious side effects with Zolsketil pegylated liposomal (which may affect more than 1 in 50 people) are neutropenia, palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome; rash and numbness on the palms and soles), leukopenia, lymphopenia (low levels of lymphocytes, a type of white blood cell), anaemia, thrombocytopaenia (low levels of blood platelets), stomatitis (inflammation of the mouth), tiredness, diarrhoea, vomiting, nausea, pyrexia (fever), dyspnoea (difficulty breathing), and pneumonia (infection of the lungs).

Zolsketil pegylated liposomal must not be used to treat Kaposi’s sarcoma that can be treated effectively with ‘local’ treatments that only affect the site of the tumour or with alfa interferons.

For the full list of side effects and restrictions of Zolsketil pegylated liposomal, see the package leaflet.

Why is Zolsketil pegylated liposomal authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Zolsketil pegylated liposomal has been shown to be comparable to the reference medicine and bioequivalent to Caelyx. Therefore, the Agency’s view was that the benefits of Zolsketil pegylated liposomal outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Zolsketil pegylated liposomal?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zolsketil pegylated liposomal have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Zolsketil pegylated liposomal are continuously monitored. Suspected side effects reported with Zolsketil pegylated liposomal are carefully evaluated and any necessary action taken to protect patients.

Other information about Zolsketil pegylated liposomal

Zolsketil pegylated liposomal received a marketing authorisation valid throughout the EU on 31 May 2022.

Zolsketil pegylated liposomal : EPAR - Medicine overview

Reference Number:

EMEA/H/C/005320

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Zolsketil pegylated liposomal : EPAR - Risk management plan summary

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Product information

Zolsketil pegylated liposomal : EPAR - Product Information

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Latest procedure affecting product information:

VR/0000340547

15/04/2026

This medicine’s product information is available in all official EU languages. Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Zolsketil pegylated liposomal : EPAR - All Authorised Presentations

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Product details

Name of medicine

Zolsketil pegylated liposomal

Active substance

doxorubicin hydrochloride, liposomal

International non-proprietary name (INN) or common name

doxorubicin

Therapeutic area (MeSH)

• Ovarian Neoplasms
• Sarcoma, Kaposi
• Multiple Myeloma

Anatomical therapeutic chemical (ATC) code

L01DB01

Pharmacotherapeutic group

doxorubicin

Therapeutic indication

Zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:

• breast cancer that has spread to other parts of the body in patients at risk of heart problems. Zolsketil pegylated liposomal is used on its own for this disease;

• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;

• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. Zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);

• Kaposi’s sarcoma in patients with AIDS who have a very damaged immune system. Kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs.

Zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance called Adriamycin. However, in Zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for Adriamycin.

Authorisation details

EMA product number

EMEA/H/C/005320

Marketing authorisation holder

Accord Healthcare S.L.U.

Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona SPAIN

Opinion adopted

24/03/2022

Marketing authorisation issued

31/05/2022

Revision

5

Assessment history

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Changes since initial authorisation of medicine

Zolsketil pegylated liposomal : EPAR - Procedural steps taken and scientific information after authorisation

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First published:

13/03/2025

Last updated:

16/04/2026

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Zolsketil pegylated liposomal : EPAR - Procedural steps taken and scientific information after authorisation (archive)

English (EN) (104.43 KB - PDF)

First published:

04/05/2023

Last updated:

13/03/2025

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Zolsketil pegylated liposomal-H-C-PSUSA-00001172-202211 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number:

EMA/400469/2023

English (EN) (106.77 KB - PDF)

First published:

05/09/2023

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Initial marketing authorisation documents

Zolsketil pegylated liposomal : EPAR - Public Assessment Report

Adopted

Reference Number:

EMA/CHMP/212114/2022

English (EN) (1.11 MB - PDF)

First published:

20/06/2022

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CHMP summary of opinion for Zolsketil pegylated liposomal

Adopted

Reference Number:

EMA/CHMP/169456/2022

English (EN) (152.29 KB - PDF)

First published:

25/03/2022

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This page was last updated on

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