Cobimetinib

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

Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).

Label history

17 changes to the Cotellic label since 2016, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes