Vemurafenib

Vemurafenib (Zelboraf, Roche Registration GmbH) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: BRAF (1).
Approved indications of Vemurafenib
Biomarker requirementRegimenSettingConditions
Melanoma1
BRAF V600
Monotherapy
Any line
advanced
None
Full text of section 4.1 (therapeutic indications)

Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (see section 5.1).

Label history

36 changes to the Zelboraf label since 2012, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes