HER2 in non-small cell lung cancer

1 EU-approved indication in non-small cell lung cancer needs a HER2 result: trastuzumab deruxtecan (2nd line, advanced).

Line of therapy

Approved indications, Non-small cell lung cancer
DrugBiomarker requirementRegimenSettingConditions
HER2 mutation1
Trastuzumab deruxtecan
Enhertuconditional
Monotherapy
2L
advanced
After platinum-based chemotherapy with or without immunotherapy

Tumour-agnostic approvals1

Approved for any solid tumour that carries the alteration, wherever the tumour started.

DrugBiomarker requirementRegimenSettingConditions
HER21
Trastuzumab deruxtecan
Enhertuconditional
HER2-positive (IHC 3+)
Monotherapy
2L
advanced
After prior treatment; No satisfactory treatment options

16 approvals for NSCLC need no biomarker and apply whatever the result. All approvals for NSCLC

See also

Label wording1

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Trastuzumab deruxtecan (Enhertu)
    Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.