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Nelarabine-Reach (nelarabine)
Sponsor
Device/Product name
Nelarabine-Reach
Active Ingredient
Nelarabine
Date of decision
Published
Submission type
Type A - New chemical entity
ATC codes
L01BB(07) - Purine analogues
Decision
Approved
What was the decision based on
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.
What steps were involved in the decision process
This submission was evaluated under the standard prescription medicines registration process
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 31 March 2023 |
| First round evaluation completed | 31 August 2023 |
| Second round evaluation completed | 29 November 2023 |
| Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice. | 20 December 2023 |
| Advisory Committee meeting | February 2024 |
| Registration decision (Outcome) | 25 March 2024 |
| Completion of administrative activities and registration on ARTG | 3 April 2024 |
| Number of working days from submission dossier acceptance to registration decision* | 203 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Black triangle scheme
Nelarabine-Reach is to be included in the Black Triangle Scheme. The PI and CMI for Nelarabine-Reach must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product. The Black Triangle Scheme identifies new prescription medicines with a black triangle on the medicine information documents. The scheme also applies to Prescription medicines being used in new ways, such as a medicine that is now being used for children. The black triangle is a visual reminder to encourage health practitioners and patients to report a problem or side effect.
Dose forms
Clear colourless solution
Strength
5 mg/mL
Other ingredients
- Sodium chloride
- Hydrochloric acid
- Sodium hydroxide
- Water for injection
Containers
Glass vial
Pack sizes
1, 6 vials.
Routes of administration
Intravenous Infusion
Dosage
The recommended dose of nelarabine for adults and adolescents aged 16 years and older is 1,500 mg/m2 administered intravenously over two hours on days 1, 3 and 5 and repeated every 21 days.
For further information refer to the Product Information.
Pregnancy category
D
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved
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.
What is this medicine and how does it work
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.
What post-market commitments will the sponsor undertake
The Nelarabine-Reach Risk Management Plan (RMP) will be implemented in Australia. An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
More information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.