1 Guidance

1 Guidance

1.1 Erlotinib is recommended as an option for treating locally advanced or metastatic non‑small‑cell lung cancer that has progressed in people who have had non‑targeted chemotherapy because of delayed confirmation that their tumour is epidermal growth factor receptor tyrosine kinase (EGFR‑TK) mutation‑positive, only if the company provides erlotinib with the discount agreed in the patient access scheme revised in the context of NICE technology appraisal guidance 258.

1.2 Erlotinib is recommended as an option for treating locally advanced or metastatic non‑small‑cell lung cancer that has progressed after non‑targeted chemotherapy in people with tumours of unknown EGFR‑TK mutation status, only if:

  • the result of an EGFR‑TK mutation diagnostic test is unobtainable because of an inadequate tissue sample or poor‑quality DNA and

  • the treating clinician considers that the tumour is very likely to be EGFR‑TK mutation‑positive and

  • the person's disease responds to the first 2 cycles of treatment with erlotinib and

  • the company provides erlotinib with the discount agreed in the patient access scheme revised in the context of NICE technology appraisal guidance 258.

1.3 Erlotinib is not recommended for treating locally advanced or metastatic non‑small‑cell lung cancer that has progressed after non‑targeted chemotherapy in people with tumours that are EGFR‑TK mutation‑negative.

1.4 Gefitinib is not recommended for treating locally advanced or metastatic non‑small‑cell lung cancer that has progressed after non‑targeted chemotherapy in people with tumours that are EGFR‑TK mutation‑positive.

1.5 People whose treatment with erlotinib or gefitinib is not recommended in this NICE guidance, but was started within the NHS before this guidance was published, should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.

  • National Institute for Health and Care Excellence (NICE)