Sunitinib Accord



This medicine is authorised for use in the European Union.


Sunitinib Accord is a medicine used to treat adults with the following cancers:

  • gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel where there is uncontrolled growth of cells in the supporting tissues of these organs. Sunitinib Accord is used in patients with GISTs that cannot be removed with surgery or have spread to other parts of the body. It is used after treatment with imatinib (another cancer medicine) has failed;
  • metastatic renal cell carcinoma, a type of kidney cancer, that has spread to other parts of the body;
  • pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) that have spread or cannot be removed with surgery. Sunitinib Accord is used if the disease is getting worse and the tumour cells are well-differentiated (similar to normal cells in the pancreas). 

Sunitinib Accord contains the active substance sunitinib and is a ‘generic medicine’. This means that Sunitinib Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Sutent.

This EPAR was last updated on 14/12/2021

Authorisation details

Product details
Sunitinib Accord
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Gastrointestinal Stromal Tumors
  • Carcinoma, Renal Cell
  • Neuroendocrine Tumors
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.


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.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Accord Healthcare S.L.U.
Edificio Este Planta 6a
World Trade Center
Moll De Barcelona S/n
08039 Barcelona

Product information

14/12/2021 Sunitinib Accord - EMEA/H/C/005419 - IA/0001

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Gastrointestinal stromal tumour (GIST)

Sunitinib Accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance.

Metastatic renal cell carcinoma (MRCC)

Sunitinib Accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.

Pancreatic neuroendocrine tumours (pNET)

Sunitinib Accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.

Assessment history

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