Entrectinib [ENT2]

Entrectinib for ROS1-positive recurrent locally advanced or metastatic non-small- cell lung cancer previously untreated with a ROS1 inhibitor therapy where the following criteria have been met:

1. This application is being 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 has histological or cytological evidence of NSCLC that carries a ROS1 gene rearrangement 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 ROS1 gene rearrangement. Please mark below on which basis the diagnosis of ROS1 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 ROS1 gene rearrangement

3. The patient has not previously received a ROS1 inhibitor. Previous treatment with crizotinib is not allowed. The NICE recommendation and the entrectinib Summary of Product Characteristics both state that entrectinib is indicated in the treatment of patients who have not been previously or treated with ROS1 inhibitors. The only exception to this is for patients who have had dose- limiting toxicity with crizotinib and it has had to be stopped within 6 months of its start and in the clear absence of progressive disease Please tick appropriately below as to whether the patient has been previously treated with systemic therapy for the recurrent/locally advanced/metastatic indication:

• no previous treatment with any systemic therapy for recurrent or locally advanced or metastatic NSCLC or
• Previous treatment with crizotinib has had to be stopped within 6 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of progressive disease

4. Entrectinib will be used only as monotherapy.
5. The patient has an ECOG performance status of 0 or 1 or 2.
6. The patient either has no brain metastases or, if the patient has brain metastases, the patient is symptomatically stable prior to starting entrectinib.
7. The patient will be treated with entrectinib until loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment, whichever is the sooner.
8. 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.
9. Entrectinib will be otherwise used as set out in its Summary of Product Characteristics.

NHS funded From: 10 November 2020

Additional information

Form version: -

CDF Managed Access: NA

NICE Technology Appraisal: TA643 (12 August 2020)

Current Form Version

Note

The data on this page was produced using version 1.381 of the CDF list, downloaded from NHS England’s website on 08 January 2026 at 14:00.

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.

Older Form Versions

There are previous versions of this form. These may not all be available on this site.

• ENT2_prior_to_cdf_1.361
• ENT2_prior_to_cdf_1.381