Alectinib monotherapy [ALE1]

For anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously untreated with an ALK inhibitor where the following criteria are met:

1. This application for alectinib is being made by and the first cycle of systemic anti-cancer therapy with alectinib 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.
3. The patient has histological or cytological evidence of NSCLC that carries an anaplastic lymphoma kinase (ALK) 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 an activating anaplastic lymphoma kinase (ALK) rearrangement. Please mark below on which basis the diagnosis of ALK 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 an activating anaplastic lymphoma kinase (ALK) rearrangement

4. patient has not previously received any ALK inhibitor for the advanced NSCLC indication unless 1st line treatment with lorlatinib, brigatinib, ceritinib or 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 disease progression or the patient was treated with adjuvant alectinib and had disease progression more than 6 months after completing treatment with adjuvant alectinib. Please mark below which of the five scenarios applies to this patient:

• the patient has never previously received an ALK inhibitor or
• the patient has previously received lorlatinib as 1st line ALK-targeted therapy and this 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 disease progression or
• the patient has previously received brigatinib as 1st line ALK-targeted therapy and this 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 disease progression or
• the patient has previously received crizotinib or ceritinib as 1st line ALK-targeted therapy and this 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 disease progression or
• the patient was previously treated with adjuvant alectinib and had disease progression more than 6 months after completing treatment with adjuvant alectinib

5. The patient is treatment-naïve to 1st line cytotoxic chemotherapy-containing systemic treatment for this locally advanced or metastatic NSCLC indication.

Note

Note: the only previous cytotoxic treatment allowed for patients to be treated with 1st line alectinib is adjuvant or neoadjuvant chemotherapy or chemotherapy given concurrently with radiotherapy.

6. The patient has an ECOG performance status of 0 or 1 or 2.
7. The patient either has no known brain metastases or if the patient has brain metastases, the patient is symptomatically stable prior to starting alectinib.
8. The patient will be treated until loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment, whichever is the sooner
9. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment.
10. The prescribing clinician is aware that a) none of brigatinib or ceritinib or crizotinib are to be used following disease progression on alectinib as there is no current clear evidence to support treatment with any of these agents after disease progression on alectinib and b) after disease progression on alectinib, the only subsequent ALK inhibitor commissioned by NHS England as next line therapy is lorlatinib. and c) after disease progression during treatment with adjuvant alectinib or within 6 months of completion of treatment with adjuvant alectinib, re-treatment with alectinib is not commissioned.
11. Alectinib will otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 07 September 2018

Additional information

Form version: 1.5

CDF Managed Access: NA

NICE Technology Appraisal: TA536 (08 August 2018)

Current Form Version

Note

The data on this page was produced using version 1.375 of the CDF list, downloaded from NHS England’s website on 09 October 2025 at 18:00.

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.