2 Information about alectinib

Marketing authorisation indication

2.1

Alectinib (Alecensa, Roche) as monotherapy is indicated 'for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)'.

Alectinib has been available in the UK through the early access to medicines scheme.

Dosage in the marketing authorisation

2.2

The recommended dose of alectinib is 600 mg (4×150 mg capsules) taken twice daily with food (total daily dose of 1,200 mg).

A validated ALK assay is necessary to identify ALK-positive NSCLC status, which should be established before alectinib therapy starts.

Treatment with alectinib should be continued until disease progression or unacceptable toxicity. Management of adverse events may need dose reduction, temporary interruption, or discontinuation of alectinib. The dose of alectinib should be reduced in steps of 150 mg twice daily based on tolerability. Alectinib should be permanently discontinued if patients cannot tolerate the 300 mg twice daily dose.