Overview

Mevlyq is a cancer medicine used to treat locally advanced or metastatic breast cancer which has continued to spread after at least one previous treatment for advanced cancer. Previous treatment should have included cancer medicines of the types known as anthracyclines and taxanes, unless these treatments were not suitable. ‘Metastatic’ means that the cancer has spread to other parts of the body.

Mevlyq is also used to treat adults with advanced or metastatic liposarcoma (a type of cancer of the soft tissues that develops from fat cells) that cannot be surgically removed. It is used in patients who have already been treated with anthracyclines (unless this treatment was not suitable).

Mevlyq is a ‘generic medicine’. This means that Mevlyq contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Mevlyq is Halaven.

For more information on generic medicines, see the question-and-answer document here.

Mevlyq contains the active substance eribulin.

Mevlyq treatment should be given under the supervision of a doctor experienced in the use of cancer medicines.

Mevlyq is given as intravenous (into a vein) injections over 21‑day cycles. The dose to be given is calculated using the patient’s height and weight. The calculated dose is given into a vein over two to five minutes on days 1 and 8 of each cycle. Doctors should consider giving patients an antiemetic (a medicine that prevents nausea and vomiting) as Mevlyq may cause nausea or vomiting.

Doses may be delayed or reduced if patients have very low levels of neutrophils (a type of white blood cell) and platelets (components that help the blood to clot) in their blood or if liver or kidney function is impaired.

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

The active substance in Mevlyq, eribulin, is similar to an anticancer substance called halichondrin B, which is found in the marine sponge Halichondria okadai. It attaches to a protein in cells called tubulin, which is important in the formation of the internal ‘skeleton’ that cells need to assemble when they divide. By attaching to tubulin in cancer cells, eribulin disrupts the formation of the skeleton, preventing the division and spread of the cancer cells.

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Halaven, and do not need to be repeated for Mevlyq.

As for every medicine, the company provided studies on the quality of Mevlyq. There was no need for ‘bioequivalence’ studies to investigate whether Mevlyq is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Mevlyq is given by injection into a vein, so the active substance is delivered straight into the bloodstream.

Because Mevlyq is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

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

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

Any additional measures in place for Halaven, such as a patient card with key safety information, also apply to Mevlyq where appropriate.

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

Mevlyq received a marketing authorisation valid throughout the EU on 09 February 2024.

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Product information

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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).

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Product details

Name of medicine
Mevlyq
Active substance
Eribulin mesylate
International non-proprietary name (INN) or common name
eribulin
Therapeutic area (MeSH)
  • Breast Neoplasms
  • Liposarcoma
Anatomical therapeutic chemical (ATC) code
L01XX41

Pharmacotherapeutic group

Other antineoplastic agents

Therapeutic indication

Mevlyq is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.

Mevlyq is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

Authorisation details

EMA product number
EMEA/H/C/006134

Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Marketing authorisation holder
YES Pharmaceutical Development Services GmbH

Basler Strasse 7
Gonzenheim
61352 Bad Homburg
Germany

Opinion adopted
14/12/2023
Marketing authorisation issued
09/02/2024

Assessment history

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