ALK

Also known as ALK fusion, ALK receptor tyrosine kinase, anaplastic lymphoma kinase

Tumour types

non-small cell lung cancer

ALK encodes a receptor tyrosine kinase; oncogenic activation in solid tumors typically arises from a chromosomal rearrangement producing an ALK fusion (most commonly EML4-ALK in NSCLC), rather than a point mutation.

Detection targets a gene fusion/rearrangement rather than a single nucleotide variant, which affects which assay modality is fit for purpose.

Clinical significance

ALK fusion-positive NSCLC is eligible for first-line ALK tyrosine kinase inhibitor therapy.
fda — FDA-approved product labeling for ALK TKIs

FDA-approved treatments

Alecensa (alectinib) — ALK-positive metastatic NSCLC (first-line and post-crizotinib) [fda]
Alunbrig (brigatinib) — ALK-positive metastatic NSCLC [ema]
Xalkori (crizotinib) — ALK-positive metastatic NSCLC [fda]
Lorbrena (lorlatinib) — ALK-positive metastatic NSCLC (first-line and later-line) [fda]

Prevalence

ALK gene rearrangements occur in approximately 3%-7% of NSCLC, more common in younger patients and never-smokers. [fda]

Tests / detection method

FISH, IHC, NGS (fusion calling)

Therapeutic pipeline

Next-generation ALK inhibitors targeting compound resistance mutations (ALK compound resistance mutations) [fda]

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