Naveruclif
Authorised
This medicine is authorised for use in the European Union
paclitaxel
MedicineHumanAuthorised
Overview
Naveruclif is used to treat the following cancers in adults:
- metastatic breast cancer, when the first treatment has stopped working and standard treatment including an anthracycline (another type of cancer medicine) is not suitable. ‘Metastatic’ means that the cancer has spread to other parts of the body;
- metastatic adenocarcinoma of the pancreas, as a first treatment in combination with another cancer medicine, gemcitabine;
- non-small cell lung cancer, as a first treatment in combination with the cancer medicine carboplatin, when the patient cannot have surgery or radiotherapy.
Naveruclif is a ‘generic medicine’. This means that Naveruclif contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Naveruclif is Abraxane. For more information on generic medicines, see the question-and-answer document here.
Naveruclif contains the active substance paclitaxel attached to a human protein called albumin.
Naveruclif can only be obtained with a prescription and should only be given under the supervision of a specialist cancer doctor in units that are specialised in giving ‘cytotoxic’ (cell-killing) medicines. It should not be interchanged with other medicines containing paclitaxel.
Naveruclif is given as an infusion into a vein over a period of 30 minutes. The recommended dose depends on the patient’s height and weight and on the condition the patient is treated for.
In metastatic breast cancer, Naveruclif is given on its own every three weeks.
In metastatic adenocarcinoma of the pancreas, Naveruclif is given in 4-week treatment cycles. The medicine is given once a day on days 1, 8 and 15 of each cycle. Immediately after giving Naveruclif, gemcitabine should be given.
In non-small cell lung cancer, treatment is carried out in 3-week cycles with Naveruclif given on days 1, 8 and 15 of each cycle and carboplatin given on day 1 immediately after Naveruclif.
For more information about using Naveruclif, see the package leaflet or contact your doctor or pharmacist.
The active substance in Naveruclif, paclitaxel, blocks a stage of cell division in which the cell’s internal ‘skeleton’ is dismantled to allow the cell to divide. By keeping this structure intact, the cells cannot divide and they eventually die. Naveruclif also affects non-cancer cells such as blood and nerve cells, which can cause side effects.
Paclitaxel has been available as a cancer medicine since 1993. In Naveruclif, as in its reference medicine Abraxane, paclitaxel is attached to a human protein called albumin in tiny particles known as ‘nanoparticles’. This makes it easy to prepare a suspension of paclitaxel, which can be infused into a vein.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Abraxane, and do not need to be repeated for Naveruclif.
As for every medicine, the company provided studies on the quality of Naveruclif. There was no need for ‘bioequivalence’ studies to investigate whether Naveruclif is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Naveruclif is given by infusion into a vein and the nanoparticles it contains rapidly separate into its constituent parts in the same way as Abraxane’s.
Because Naveruclif 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, Naveruclif has been shown to be comparable to Abraxane. Therefore, the Agency’s view was that, as for Abraxane, the benefits of Naveruclif 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 Naveruclif have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Naveruclif are continuously monitored. Suspected side effects reported with Naveruclif are carefully evaluated and any necessary action taken to protect patients.
Naveruclif received a marketing authorisation valid throughout the EU on 5 January 2024.
This overview was last updated in 01-2024.
Product information
05/01/2024
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).
Product details
- Name of medicine
- Naveruclif
- 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
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Naveruclif 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).
Naveruclif in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Naveruclif 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.
News on Naveruclif
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