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ALK

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

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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

  • PubMed Central · Aug 20, 2026

    Clinical Evaluation of Anaplastic Lymphoma Kinase (ALK) Inhibitors for the First-Line Treatment of Advanced ALK-Positive Non-Small Cell Lung Cancer Based on the 2nd Edition of China's Drug Evaluation and Selection Guideline.

    Read at PubMed Central
  • PubMed Central · Aug 19, 2026

    Three decades of anaplastic lymphoma kinase: from physiological roles to cancer and immune evasion.

    Read at PubMed Central
  • PubMed Central · Aug 14, 2026

    Targeted immunotherapies for anaplastic lymphoma kinase-positive pediatric tumors: current advances and future perspectives.

    Read at PubMed Central
  • PubMed Central · May 22, 2026

    Primary Pulmonary Epithelioid Inflammatory Myofibroblastic Sarcoma With SQSTM1::ALK Fusion.

    Read at PubMed Central