Summary

• Vandetanib should not be administered to patients in whom rearranged during transfection (RET) mutation status is not known or is negative.
• Restriction of the indication is based on data from the randomized study D4500C00058, and the observational study OBS14778, showing insufficient activity of vandetanib in patients with no identified RET mutations. 
• Prior to initiation of treatment with vandetanib, the presence of a RET mutation should be determined by a validated test.
• For patients currently under treatment and for which the RET status remains unknown or is negative, healthcare professionals are recommended to discontinue treatment taking into account their judgement of the patients’ clinical response and the best treatment available.