Tibsovo
Registration timeline
The following table summarises the key steps and dates for this application.
|
Description |
Date |
|---|---|
|
Submission dossier accepted and first round evaluation commenced
|
31 August 2022
|
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
5 July 2023 and 14 August 2023
|
|
Advisory Committee meeting |
Not applicable
|
|
Registration decision (Outcome) |
15 September 2023
|
|
Completion of administrative activities and registration on ARTG |
20 September 2023
|
|
Number of working days from submission dossier acceptance to registration decision* |
215
|
*Statutory timeframe for standard applications is 255 working days
Colloidal anhydrous silica, croscarmellose sodium, hypromellose, hypromellose acetate succinate, indigo carmine aluminium lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, titanium dioxide, triacetin.
The recommended dose of Tibsovo is 500 mg orally once daily until disease progression or unacceptable toxicity. When Tibsovo is used in combination with azacitidine to treat patients with newly diagnosed acute myeloid leukaemia (AML), the recommended dose of azacitidine is 75 mg/m2 of body surface area, intravenously or subcutaneously, once daily on Days 1 to 7 (or on Days 1 to 5, then on Days 8 and 9) of each 28-day cycle. Refer to the full Product Information (PI) for azacitidine for additional dosing information.
Continue treatment for AML (whether monotherapy or in combination with azacitidine) for a minimum of six months to allow time for clinical response.
For further information refer to the Product Information.
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.
Acute myeloid leukaemia
Tibsovo is indicated for the treatment of acute myeloid leukaemia (AML) that carries an IDH1 R132 mutation:
- as monotherapy, or in combination with azacitidine, in newly diagnosedpatients who are not eligible to receive intensive induction chemotherapy; or
- as monotherapy in patients whose AML is relapsed and/or refractory to priortherapy.
- Tibsovo (ivosidenib) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Tibsovo 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 Tibsovo EU [European Union]-risk management plan (RMP) (version 1.0, dated 17 February 2023; DLP [data lock point] 31 October 2021), with Australia specific annex (version 1.3, dated August 2023), included with Submission PM-2022-02178-1-6, and any subsequent revisions, as agreed with 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 [Revision 1], Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.
Further information
The latest Product Information (PI) and Consumer Medicines 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.