Published

May 11, 2025

Entrectinib [ENT1a]

Entrectinib for the treatment of patients aged 12 and over who have solid tumours (including primary cerebral tumours) that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion AND disease which is locally advanced or metastatic or for which surgical resection is likely to result in severe morbidity AND who have no satisfactory treatment options where the following criteria have been met: This ENT1a form is for the initiation of treatment with entrectinib and is only for funding of the first TWELVE weeks of entrectinib treatment. PET/CT/MR scans of index assessable/measureable disease and also of the brain must be done prior to commencing entrecinib and repeated at 10 weeks after the start of treatment (if not indicated before 10 weeks on account of assessing risk of disease progression). A RECIST response on the repeated assessment must be made. Form ENT1b which requires information as to this RECIST response assessment must then be completed for continuation of funding for entrectinib beyond the initial 12 week period otherwise the dispensing Trust will not receive reimbursement for further entrectinib. Form ENT2 is for the use of entrectinib in patients with ROS1 non small cell lung cancer.

  1. This application is made by and the first cycle of systemic anti-cancer therapy with entrectinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient is aged 12 years or older. Entrectinib is only licensed in those aged 12 and above. If the patient is aged under 12 years, larotrectinib is licensed in this age group and can be accessed via form LAR1a.
  3. This patient has a proven histological diagnosis of a malignant solid tumour (ie a carcinoma or a sarcoma or melanoma or a brain or spinal cord tumour) and does NOT have a leukaemia or a lymphoma or myeloma. Please state below the site of origin of the patient’s cancer and its specific histological type.
  4. This patient has disease that is locally advanced or metastatic or would require surgical resection likely to result in severe morbidity. Please enter below the type of disease that is being treated:
  • locally advanced disease for which systemic therapy has been indicated or
  • metastatic disease or
  • locally advanced disease for which surgical resection is likely to result in severe morbidity. Please state in the box below the type of surgical resection which would otherwise have been needed and resulted in severe morbidity.
  1. This patient has no satisfactory systemic therapy options. A satisfactory systemic treatment option is defined as one which is funded by NHS England for the disease and indication in question. By ticking the adjacent ‘yes’ box, I confirm that the patient has already been treated with all the systemic therapy options funded by NHS England for the disease in question. As part of the evidence that NICE and NHS England wish to see at the NICE re-appraisal of entrectinib in NTRK gene fusion positive patients, data will be specifically analysed as to systemic therapies before and after entrectinib in order to test whether entrectinib has been used after all NHS-funded systemic therapies have been used. Please enter below the number of lines of systemic therapy the patient has received for the locally advanced/metastatic indication:
  • 1 line of systemic therapy for locally advanced/metastatic disease or
  • 2 lines of systemic therapy for locally advanced/metastatic disease or
  • 3 or more lines of systemic therapy for locally advanced/metastatic disease.
  • Entrectinib is being used as first line therapy for locally advanced/metastatic disease, as the patient has no satisfactory systemic therapy options, as described above.
  1. This patient HAS a documented NTRK gene fusion in the tumour and this has been determined with appropriate nucleic acid-based assay(s). Please enter below which NTRK gene is involved in the gene fusion:
  • in NTRK1 or
  • in NTRK2 or
  • in NTRK3 Please also enter the NTRK gene fusion partner. Please also enter the name of the testing laboratory which performed the NTRK gene fusion test.
  1. The patient has not previously received treatment with any tropomyosin receptor tyrosine kinase (TRK) inhibitor.
  2. Entrectinib will be used as monotherapy.
  3. The patient has an ECOG performance status (PS) of 0 or 1 or 2. Note: a patient with a performance status of 3 or more is not eligible for entrectinib.
  4. A PET/CT/MR scan of index assessable/measureable disease has been done prior to commencing entrectinib and that this will be repeated 10 weeks after the start of treatment (if not indicated before 10 weeks on account of assessing risk of disease progression).
  5. The patient has had a recent CT or MR scan of the brain and either has no brain metastases or, if the patient has brain metastases, the patient is symptomatically stable prior to starting entrectinib. Please enter below as to whether the patient has radiological evidence of brain metastases and the patient’s previous treatment for brain metastases:
  • the patient does not have brain metastases or
  • the patient does have brain metastases and has not received any cerebral surgery and/or radiotherapy and is symptomatically stable or
  • the patient does have brain metastases and has received previous cerebral surgery and/or radiotherapy and is symptomatically stable. Note: repeat imaging of the brain is required at week 10 after commencing entrectinib.
  1. Entrectinib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment or potentially curative surgery takes place.
  2. The prescribing clinician is fully aware of the likely toxicities of entrectinib as listed in its SPC and am aware that a significant rate of bone fractures has been reported in patients treated with entrectinib.
  3. A formal medical review as to whether treatment with entrectinib should continue or not (on basis of being fit to continue treatment) will be scheduled to occur by the start of the second cycle (month) of treatment.
  4. No treatment breaks of more than 6 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or intercurrent comorbidities to improve).
  5. Entrectinib is to be otherwise used as set out in its Summary of Product Characteristics

CDF funded From: 25 June 2020

Form version:

CDF Managed Access: Yes

NICE Technology Appraisal: NA (NA)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

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.