Direct Healthcare Professional Communication (DHPC) on Caprelsa® (vandetanib): Restriction of indication
2023.01.02
Active substance: vandetanib
Notice (added on 27.02.2023)
This DHPC contains a typo in the description of RET status reanalysis in study 58, included in the ‘Background information’ section.
Correct lines 30-32 on p. 2 should read, „At 2 years, 55.7% of RET mutant positive patients treated with vandetanib had no disease progression versus 40.1% of RET mutant positive patients treated with placebo.“
Sanofi in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices would like to inform you of data from the randomized study D4500C00058, and the observational study OBS14778, showing insufficient activity of vandetanib in patients with no identified RET mutations. Vandetanib should not be administered to patients in whom rearranged during transfection (RET) mutation status is not known or is negative. For patients with unknown or negative RET status who are currently being treated, healthcare professionals are advised to discontinue treatment, taking into account the patient's clinical response and the best available treatment option.
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