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Nelarabine-Reach (nelarabine)
Australian Prescription Medicine Decision Summary
Published
Product name
Nelarabine-Reach
Active ingredient
Nelarabine
Submission type
Type A - New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Nelarabine-Reach (nelarabine) is a drug used to treat cancer. It was specifically approved for the following therapeutic use:
Nelarabine is indicated for the treatment of patients with relapsing/refractory T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment.
Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.
How this medicine works
Nelarabine belongs to a class of anti-cancer drugs called “anti-metabolites” which mimic the building blocks of DNA in rapidly replicating cells, such as cancer cells. Once the drug is incorporated into the DNA of these cells, the DNA is prevented from replicating and the cells are unable to multiply. This results in cell death. Once inside rapidly dividing cells, nelarabine is converted into a toxic analogue of guanine, a key component of DNA. Incorporation of this toxic guanine metabolite of nelarabine into dividing cancer cells results in their death. Nelarabine is particularly effective for T and B cell cancers as this analogue accumulates and persists for longer in these cell types.
Why the TGA approved or did not approve this medicine
The decision was based on literature reports describing the efficacy and safety of nelarabine in paediatric and adult patients with relapsing/refractory T-ALL and T-LBL whose disease had progressed on two or more chemotherapy regimens. The efficacy and safety of nelarabine was supported by the submitted literature findings. The application was literature-based given the availability of nelarabine on global markets for over 15 years.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlink below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlink below.
Sponsor
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.