Atriance

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nelarabine

Authorised
This medicine is authorised for use in the European Union.

Overview

Atriance is a cancer medicine used to treat patients with T-cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL). These are types of cancer where T-lymphoblasts (a type of immature white blood cell) multiply too quickly. In T-ALL the abnormal cells are mainly in the blood and bone marrow, and in T-LBL they are mainly in the lymphatic system (lymph nodes or thymus gland). Atriance is used when the cancer has not responded to, or has stopped responding to, at least two types of chemotherapy.

Atriance contains the active substance nelarabine. 

This EPAR was last updated on 22/01/2020

Authorisation details

Product details
Name
Atriance
Agency product number
EMEA/H/C/000752
Active substance
nelarabine
International non-proprietary name (INN) or common name
nelarabine
Therapeutic area (MeSH)
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Anatomical therapeutic chemical (ATC) code
L01BB07
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.

Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
22/08/2007
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

17/10/2019 Atriance - EMEA/H/C/000752 - II/0046/G

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

Due to the small patient populations in these disease settings, the information to support theseindications is based on limited data.

Assessment history

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