Selpercatinib (5) – Retsevmo®

• Clinical trials
  • The EXAM trial is a double-blind, international, multicentre RCT comparing cabozantinib with placebo.

Adults and adolescents aged 12 years and over with advanced medullary thyroid carcinoma with a RET receptor tyrosine kinase (rearranged during transfection – RET) mutation; first-line treatment

• The additional benefit is not proven.
• Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; therefore, the additional benefit of selpercatinib as monotherapy in adults and adolescents aged 12 years and over with advanced RET-mutated medullary thyroid carcinoma (MTC) is not proven.
• Overall assessment
  • The results of the single-arm LIBRETTO-001 study submitted on their own are not suitable for assessing the additional benefit of selpercatinib, as they do not allow for a comparison with the appropriate comparator therapy.
  • The indirect comparison presented, comprising individual arms from various studies in the form of an unweighted comparison, is not suitable for drawing conclusions regarding additional benefit, as the studies are not comparable on either the intervention or control sides with regard to the patients included.
  • Overall, the indirect comparisons presented are not suitable for demonstrating additional benefit over the appropriate comparator therapy; consequently, the additional benefit of selpercatinib as monotherapy in adults and adolescents aged 12 years and over with advanced medullary, It is not proven that the RET receptor tyrosine kinase (rearranged during transfection – RET) mutation is present in first-line treatment.

Courtesy translation only, please refer to the German original.