Overview

On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Apexelsin, intended for the treatment of metastatic breast cancer, metastatic adenocarcinoma of the pancreas and non-small cell lung cancer.

The applicant for this medicinal product is WhiteOak Pharmaceutical B.V.

Apexelsin will be available as 5 mg/ml powder for dispersion for infusion. The active substance of Apexelsin is paclitaxel, a taxane antineoplastic agent (ATC code: L01CD01). Paclitaxel interferes with microtubule growth to block cell division and induces apoptosis. Paclitaxel also affects non-cancer cells such as blood and nerve cells, which can cause side effects.

Apexelsin is a generic of Abraxane, another nanoparticle albumin-bound paclitaxel, which has been authorised in the EU since 2008. Studies have demonstrated the satisfactory quality of Apexelsin. A bioequivalence study versus the reference product was not required because Apexelsin is administered intravenously and the nanoparticles dissociate rapidly, and because of the qualitative and quantitative comparability of the products. A question and answer document on generic medicines can be found here.

The full indication is:

Apexelsin monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated (see section 4.4).

Apexelsin in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.

Apexelsin in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.

Apexelsin should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents. It should not be substituted for or with other paclitaxel formulations.

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 Apexelsin

AdoptedReference Number: EMEA/250328/2024

English (EN) (102.88 KB - PDF)

First published:
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Product details

Name of medicine
Apexelsin
Active substance
paclitaxel
International non-proprietary name (INN) or common name
paclitaxel
Therapeutic area (MeSH)
  • Breast Neoplasms
  • Pancreatic Neoplasms
  • Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01CD01
EMA product number
EMEA/H/C/005997

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 applicant
Whiteoak Pharmaceutical B.V.
Opinion adopted
30/05/2024
Opinion status
Positive
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