Axitinib Accord
Authorised
This medicine is authorised for use in the European Union
axitinib
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Axitinib Accord is used to treat adults with advanced renal cell carcinoma, a type of kidney cancer. ‘Advanced’ means that the cancer has started to spread. Axitinib Accord is used when treatment with a medicine containing sunitinib or with ‘cytokines’ (other cancer medicines) has failed.
Axitinib Accord contains the active substance axitinib and is a ‘generic medicine’. This means that Axitinib Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Axitinib Accord is Inlyta. For more information on generic medicines, see the question-and-answer document here.
Axitinib Accord can only be obtained with a prescription and treatment should be started by a doctor with experience in using cancer medicines.
Axitinib Accord is available as tablets to be taken twice a day. The dose can be adjusted according to the patient’s response. It may be necessary to reduce the dose or interrupt treatment to manage certain side effects. In patients taking certain other medicines, the doctor may need to adjust the dose of Axitinib Accord.
Patients with moderately reduced liver function should receive a lower starting dose. Axitinib Accord should not be used in patients with severely reduced liver function.
For more information about using Axitinib Accord, see the package leaflet or contact your doctor or pharmacist.
The active substance in Axitinib Accord, axitinib, works by blocking some enzymes (proteins) known as tyrosine kinases that are found in vascular endothelial growth factor (VEGF) receptors on the surface of cancer cells. VEGF receptors are involved in the growth and spread of cancer cells and in the development of blood vessels that supply the tumours. By blocking these receptors, Axitinib Accord helps to reduce the growth and spread of the cancer and cut off the blood supply that keeps the cancer cells growing.
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Inlyta, and do not need to be repeated for Axitinib Accord.
As for every medicine, the company provided studies on the quality of Axitinib Accord. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. 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.
Because Axitinib Accord 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, Axitinib Accord has been shown to have comparable quality and to be bioequivalent to Inlyta. Therefore, the Agency’s view was that, as for Inlyta, the benefits of Axitinib Accord 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 Axitinib Accord have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Inlyta also apply to Axitinib Accord, where appropriate.
As for all medicines, data on the use of Axitinib Accord are continuously monitored. Suspected side effects reported with Axitinib Accord are carefully evaluated and any necessary action taken to protect patients.
Axitinib Accord received a marketing authorisation valid throughout the EU on 19 September 2024.
Product information
Latest procedure affecting product information:
IB/0001
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
- Axitinib Accord
- Active substance
- axitinib
- International non-proprietary name (INN) or common name
- axitinib
- Therapeutic area (MeSH)
- Carcinoma, Renal Cell
- Anatomical therapeutic chemical (ATC) code
- L01EK01
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Axitinib Accord is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.
News on Axitinib Accord
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