Vandetanib

Vandetanib (Caprelsa, Esteve Pharmaceuticals, S.A.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: RET (1).
Approved indications of Vandetanib
Biomarker requirementRegimenSettingConditions
Thyroid cancer1
RET mutation
Monotherapy
Any line
advanced
Medullary thyroid cancer only; Aggressive and symptomatic disease; aged 5 years and older
Full text of section 4.1 (therapeutic indications)

Caprelsa is indicated for the treatment of aggressive and symptomatic Rearranged during Transfection (RET) mutant medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Caprelsa is indicated in adults, children and adolescents aged 5 years and older.

Label history

31 changes to the Caprelsa label since 2013, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes