Human medicines European public assessment report (EPAR): Mevlyq, eribulin, Status: Opinion
Overview
On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Mevlyq, intended for the treatment of adult patients with locally advanced or metastatic breast cancer, or adult patients with unresectable advanced or metastatic liposarcoma.
The applicant for this medicinal product is YES Pharmaceutical Development Services GmbH.
Mevlyq will be available as a solution for injection (0.44 mg/ml). The active substance of Mevlyq is eribulin, an antineoplastic agent (ATC code: L01XX41). Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage.
Mevlyq is a generic of Halaven, which has been authorised in the EU since 17 March 2011. Since Mevlyq is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product Halaven was not required. A question and answer document on generic medicines can be found here.
The full indication is:
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 (see section 5.1). 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 (see section 5.1).
Mevlyq should be prescribed by physicians experienced in the appropriate use of cytotoxic medicinal products.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
CHMP summary of positive opinion for Mevlyq
AdoptedFirst published: Reference Number: EMA/CHMP/543409/2023
Product details
- Name of medicine
Mevlyq
- Active substance
Eribulin mesylate
- International proprietary name (INN) or common name
eribulin
- Therapeutic area (MeSH)
- Breast Neoplasms
- Liposarcoma
- Anatomical therapeutic chemical (ATC) code
L01XX41
- EMA product number
EMEA/H/C/006134
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 applicant
YES Pharmaceutical Development Services GmbH
- Opinion adopted
14/12/2023
- Opinion status
Positive
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