Sonidegib

Sonidegib (Odomzo, Sun Pharmaceutical Industries Europe B.V.) has 1 EU-approved indication in 1 tumour type.
Approved indications of Sonidegib
Biomarker requirementRegimenSettingConditions
Basal cell carcinoma1
None
Monotherapy
Any line
locally adv.
Not amenable to curative surgery or radiation therapy
Full text of section 4.1 (therapeutic indications)

Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.

Label history

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

Changes