Alectinib [ALE2]

Alectinib monotherapy for adjuvant treatment in adults after complete tumour resection in patients with UICC/AJCC 8th TNM edition stage IB (4cm only) or IIA or IIB or IIIA or N2 only IIIB non-small cell lung cancer whose tumours have an ALK gene rearrangement where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with adjuvant alectinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has a histologically documented non-small cell lung cancer (NSCLC).
3. The patient has undergone a complete resection of the NSCLC with all surgical margins negative for tumour.
4. The pathological stage determined on this patient’s surgical NSCLC specimen was a stage IB (4cm only) or IIA or IIB or IIIA or N2 only IIIB tumour according to the UICC/AJCC TNM 8th edition. Please mark below which stage applies to this patient:

• stage IB disease in which the primary is no less than and no more than 4cm in diameter (T2a N0)
• stage IIA disease (T2b N0)
• stage IIB disease (T1a N1 or T1b N1 or T1c N1 or T2a N1 or T2b N1 or T3 N0)
• stage IIIA disease (T1a N2 or T1b N2 or T1c N2 or T2a N2 or T2b N2 or T3 N1 or T4 N0 or T4 N1)
• N2 only stage IIIB disease (T3 N2 or T4 N2)

5. The patient’s NSCLC has been documented on the tumour specimen (biopsy or surgical specimen) as exhibiting an anaplastic lymphoma kinase (ALK) gene arrangement.
6. The patient did not receive any pre-operative systemic therapy (cytotoxic chemotherapy, immunotherapy, ALK-targeted tyrosine kinase inhibitors) for the NSCLC.
7. The patient did not receive any pre-operative or post-operative radiation therapy for the NSCLC.
8. No more than 12 weeks have elapsed since surgery
9. The patient has had no prior treatment with an ALK-targeted drug.
10. The patient has an ECOG performance status (PS) of 0 or 1.
11. The patient does not have brain metastases on CT or MR imaging of the brain done either before surgery or prior to this application.
12. Alectinib will be administered as monotherapy.
13. The patient will be treated with alectinib for whichever is the sooner of: disease progression or unacceptable toxicity or withdrawal of patient consent or for a total treatment duration of 2 calendar years.
14. A formal medical review as to how alectinib is being tolerated and whether treatment with alectinib should continue or not will be scheduled to occur at least by the end of the second 4-weekly cycle of treatment.
15. 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.
16. Alectinib will be used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 16 October 2024 - anticipated to move to NHS funding: 11 February 2025

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