Tepotinib [TEP1]

Tepotinib as monotherapy for the treatment of adult patients with untreated advanced/metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations where the following criteria are met:

  1. This application for tepotinib is being made by and the first cycle of systemic anti-cancer therapy with tepotinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has locally advanced or metastatic non-small cell lung cancer. Please indicate below whether the patient has non-squamous or squamous NSCLC:
  • non-squamous NSCLC or
  • squamous NSCLC
  1. The patient has histological or cytological evidence of NSCLC that carries a MET exon 14 skipping alteration based on a validated test OR there is documented agreement by the lung MDT that the radiological appearances are in keeping with locally advanced or metastatic NSCLC AND there is an informative circulating free DNA test result confirming the presence of a MET exon 14 skipping alteration. Please mark below on which basis the diagnosis of a MET exon 14 skipping alteration positive NSCLC has been made in this patient:
  • Histological or cytological evidence.
  • Documented agreement by the lung MDT that the radiological appearances are in keeping with locally advanced or metastatic NSCLC and there is an informative circulating free DNA test result confirming the presence of a MET exon 14 skipping alteration
  1. The patient’s lung cancer is of EGFR wild type and is also negative for both ALK and ROS1 gene rearrangements.
  2. This patient is treatment-naïve as regards to systemic therapy for the locally advanced or metastatic NSCLC indication.
  3. The patient has not been previously treated with a drug specifically targeting a MET exon 14 skipping alteration unless the patient received tepotinib via the EAMS program and the patient meets all the other treatment criteria on this form.
  4. The patient has an ECOG performance status (PS) score of 0 or 1.
  5. The patient either has no known brain metastases or if the patient does have brain metastases then the patient is symptomatically stable before staring tepotinib. Please mark below the status with respect to known brain/CNS metastases:
  • the patient has never had known brain/CNS metastases
  • the patient has had brain/CNS metastases treated before with surgery/radiotherapy and is currently symptomatically stable
  • the patient has brain secondaries which have not been treated with surgery/radiotherapy and is currently symptomatically stable
  1. Tepotinib will be used as monotherapy.
  2. The prescribing clinician is aware of the side-effects of tepotinib including the risk of developing oedema, interstitial lung disease and hepatotoxicity.
  3. The prescribing clinician is aware of the potential drug interactions that may occur with tepotinib as set out in tepotinib’s Summary of Product Characteristics (SPC) including the potential interaction with metformin.
  4. The patient will be treated until loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment whichever is the sooner.
  5. A formal medical review as to how tepotinib is being tolerated will be done before the start of the second month of treatment and the next review to determine whether treatment with tepotinib should continue or not will be scheduled to occur at least by the end of the second month of therapy.
  6. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, including as appropriate if the patient has had an extended break on account of Covid-19.
  7. Tepotinib will otherwise be used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 17 June 2022

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CDF Managed Access: NA

NICE Technology Appraisal: TA789 (18 May 2022)

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Note

The data on this page was produced using version 1.343 of the CDF list, downloaded from an archive of NHS England’s website on 26 January 2025 at 22:41.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

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