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27 January 2022

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
Active ingredients
Tepotinib (as hydrochloride monohydrate)
ATC codes
Approved for provisional registration
Date of decision
11 January 2022
Date of entry onto ARTG
17 January 2022
Original publication date
27 January 2022
ARTG numbers
Black Triangle Scheme


As a provisionally registered product, this medicine will remain in the Black Triangle Scheme for the duration of its provisional registration.

Merck Healthcare Pty Ltd
Sponsor address
Suite 1, Level 1, Building B 11 Talavera Road, Macquarie Park NSW 2113
Dose forms
Film coated tablet
225 mg tepotinib (equivalent to 250 mg tepotinib hydrochloride monohydrate)
Other ingredients

Tablet core: mannitol, colloidal anhydrous silica, crospovidone, magnesium stearate, microcrystalline cellulose

Film coating: hypromellose, lactose monohydrate, macrogol 3350, triacetin, iron oxide red, titanium dioxide

Blister pack
Pack sizes
60 tablets
Routes of administration

Treatment should be initiated and supervised by a physician experienced in the treatment of cancer.

The recommended dose of Tepmetko is 450 mg (two 225 mg tablets) orally once daily with food. Treatment should continue as long as clinical benefit is observed.

For further information refer to the Product Information.

Pregnancy category


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?

Tepmetko (tepotinib) was approved for the following therapeutic use:

Tepmetko has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).

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?

  • Tepmetko (tepotinib) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Tepmetko must include the black triangle symbol and mandatory accompanying text for the products entire period of provisional registration.
  • Confirmatory trial data (as identified in the sponsor's plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that registration would commence) must be provided.

    Specifically, the sponsor must conduct studies as described in the clinical study plan inversion 2.1 (dated 27 July 2021) of the Australia specific annex. The following study report should be submitted to TGA:

    Study MS200095-0022, VISION, by date 1 November 2027

    Further guidance for sponsors is available on the TGA website.

  • The Tepmetko Core-risk management plan (RMP) (version 3.0 dated 10 May 2021; data lock point (DLP) 1 July 2020) and Australian specific annex version 2.1 (dated 27 July 2021) included with submission PM-2021-03109-1-4, 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, or the entire period of provisional registration, whichever is longer.

    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. Each report must have been prepared within ninety calendar days of the data lock point for that report.

  • Submit final reports including datasets from clinical studies to confirm and further characterise the clinical benefit of tepotinib for the treatment of patients with non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations who are treatment-naïve and who have previously received systemic therapy, by providing a more precise estimation of the blinded independent central review-assessed overall response rate and duration of response.
  • Conduct a drug interaction study to evaluate the effect of itraconazole on the single dose pharmacokinetics of tepotinib to assess the magnitude of increased drug exposure and determine appropriate dosing recommendations when tepotinib is administered concomitantly with a strong CYP3A4 and P-gp inhibitors.
  • Conduct a drug interaction study to evaluate the effect of carbamazepine on the single dose pharmacokinetics of tepotinib to assess the magnitude of decreased drug exposure and determine appropriate dosing recommendations when tepotinib is administered concomitantly with a strong CYP3A4 inducer and moderate CYP2C8 inducer.

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.