Capmatinib

Capmatinib (Tabrecta, Novartis Europharm Limited) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: MET (1).
Approved indications of Capmatinib
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer1
Alterations leading to METex14 skipping
Monotherapy
2L
advanced
After prior treatment with immunotherapy and/or platinum-based chemotherapy
Full text of section 4.1 (therapeutic indications)

Tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Label history

4 changes to the Tabrecta label since 2023, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes