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Xospata

11 April 2020

The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.

Australian prescription medicine decision summary

Summary of submission

Submission type
New chemical entity
Product name

Xospata

Active ingredients
Gilteritinib (as fumarate)
ATC codes
L01XE54
Decision
Approved
Date of decision
26 March 2020
Date of entry onto ARTG
2 April 2020
Original publication date
11 April 2020
ARTG numbers
321060
Black Triangle Scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia
Sponsor
Astellas Pharma Australia Pty Ltd
Sponsor address
6 Eden Park Drive, Macquarie Park NSW 2113
Dose forms
Film coated tablet
Strength
40 mg
Other ingredients

Tablet core: Mannitol, Hyprolose, Magnesium Stearate

Coating: Hypromellose, Purified talc, Macrogol 8000, Titanium dioxide, Iron oxide yellow

Containers
Blister pack
Pack sizes
84 film coated tablets (21 tablets x 4 blisters)
Routes of administration
Oral
Dosage

Treatment with Xospata should be initiated and supervised by a physician experienced in the use of anti-cancer therapies.

Before taking Xospata, relapsed or refractory AML patients must have confirmation of FMS-like tyrosine kinase 3 (FLT3) mutation (internal tandem duplication (ITD) or tyrosine kinase domain (TKD)).

Dosage

The recommended starting dose of Xospata is 120 mg (three 40 mg tablets) once daily.

Blood chemistries, including creatine phosphokinase, should be assessed prior to initiation of treatment, on Day 15 and monthly for the duration of treatment.

An electrocardiogram (ECG) should be performed before initiation of Xospata treatment, on Day 8 and 15 and prior to the start of the next three subsequent months of treatment. In addition, an ECG should be performed following the same schedule in case of dose increase (see Product Information Section 4.4 Special warnings and precautions for use and section 4.8 Adverse effects (Undesirable effects)).

Treatment should continue until the patient is no longer clinically benefiting from Xospata or until unacceptable toxicity occurs. Response may be delayed; therefore, continuation of treatment at the prescribed dose for up to 6 months should be considered to allow time for a clinical response.

In the absence of a response (patient did not achieve a composite complete remission (CRc)) after 4 weeks of treatment, the dose can be increased to 200 mg (five 40 mg tablets) once daily, if tolerated or clinically warranted.

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. Accompanying texts should be consulted for further details.

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?

Xospata (gilteritinib (as fumarate)) was approved for the following therapeutic use:

Xospata is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.

What is this medicine and how does it work?

What was the decision based on?

What steps were involved in the decision process?

What post-market commitments will the sponsor undertake?

  • Xospata (gliteritinib) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Xospata 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 Xospata European Union-Risk Management Plan (EU-RMP) (version 1.0, dated 4 October 2019, data lock point 17 September 2018), with Australian specific Annex (version 0.6, dated Feb 2020), included with submission PM-2019-03406-1-6, to be revised to the satisfaction of the TGA, 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).

    Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of the approval letter.

    The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.

  • In relation to health care professional education material for differentiation syndrome, the sponsor is instructed to: (1) update the ASA with information on how it will be implemented in Australia (including target audience, method of dissemination, timeframe for implementation and how it will be evaluated); (2) provide a copy of the materials including Black Triangle symbol and wording for review and approval prior to product supply; and (3) implement an evaluation of the effectiveness of the material through assessing healthcare professional awareness and clinical knowledge of differentiation syndrome (for example using a cross-sectional study among healthcare professionals).

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.