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Tibsovo
Device/Product name
Tibsovo
Active Ingredient
Ivosidenib
Date of decision
Published
Submission type
New Chemical Entity
ATC codes
L01XX62
Decision
Approved
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application, evaluated through Priority Review.
|
Description |
Date |
|
Submission dossier accepted and first round evaluation commenced
|
1 August 2022 |
|
Evaluation completed |
27 October 2022 |
|
Sponsor provides responses on questions raised in first round evaluation |
22 September 2022 |
|
Second round evaluation completed |
21 December 2022 |
|
Delegate’s Overall benefit-risk assessment |
31 March 2023 |
|
Sponsor’s pre-Advisory Committee response |
Not applicable |
|
Advisory Committee meeting |
Not applicable |
|
Registration decision (Outcome) |
4 April 2023 |
|
Completion of administrative activities and registration on ARTG |
5 April 2023 |
|
Number of working days from submission dossier acceptance to registration decision* |
136 |
*Target timeframe for priority applications is 150 working days from acceptance for evaluation to the decision.
Date of entry onto ARTG
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
Dose forms
Film coated tablet
Strength
250 mg
Other ingredients
Colloidal anhydrous silica, croscarmellose sodium, hypromellose acetate succinate, Hypromellose, indigo carmine aluminium lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, titanium dioxide, triacetin
Containers
Bottle
Pack sizes
60
Routes of administration
Oral
Dosage
Treatment should be initiated by a physician experienced in the use of anti-cancer therapies.
Before taking Tibsovo, patients must have confirmation of an IDH1 mutation using an appropriate diagnostic test, and an electrocardiogram (ECG) to assess heart rate-corrected QT (QTc) interval.
The recommended dose of ivosidenib is 500 mg orally once daily until disease progression or unacceptable toxicity. Tibsovo should be taken at about the same time each day, with or without food, but not with a high fat meal.
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.
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
Tibsovo (ivosidenib) was approved for the following therapeutic use:
Tibsovo is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) R132 mutation after at least one prior line of systemic therapy.
What is this medicine and how does it work
Ivosidenib is a small molecule inhibitor of R132-mutated isocitrate dehydrogenase 1 (IDH1) enzymes. Through a gain of neomorphic function, the mutant IDH1 converts alpha-ketoglutarate (α-KG) to 2- hydroxyglutarate (2-HG). As 2-HG competitively inhibits α-KG-dependent enzymes, including histone and deoxyribonucleic acid (DNA) demethylases, its accumulation leads to widespread epigenetic dysregulation. Ivosidenib inhibited selected IDH1 mutants (R132C, R132L, R132G, R132H and R132S) at much lower concentrations than wild-type IDH1 in vitro.
What post-market commitments will the sponsor undertake
- Tibsovo (ivosidenib) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicine 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 0.1, dated 1 March 2022, data lock point 31 October 2021), with Australia specific annex (version 0.3, dated 27 January 2023), included with Submission PM-2022-02134-1-4, to be updated to the satisfaction of the TGA, 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).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report 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.