Selpercatinib (2) – Retsevmo®

Adults and adolescents aged 12 years and over with advanced medullary thyroid carcinoma (MTC); with a RET receptor tyrosine kinase (rearranged during transfection – RET) mutation, for whom systemic therapy is indicated; following prior treatment with cabozantinib and/or vandetanib

• For the treatment of adults and adolescents aged 12 years and over with advanced medullary thyroid carcinoma (MTC); with a RET receptor tyrosine kinase (rearranged during transfection – RET) mutation; in whom systemic therapy is indicated; following prior treatment with cabozantinib and/or vandetanib, additional benefit is not proven.
• Consequently, there are no suitable data available for assessing the additional benefit of selpercatinib compared with the appropriate comparator therapy. Therefore, the additional benefit is not proven.
• The results from the LIBRETTO-001 study alone are not suitable for assessing the additional benefit of selpercatinib, as they do not allow for a comparison with the appropriate comparator therapy.
• The pharmaceutical manufacturer has submitted a non-adjusted indirect comparison. The comparisons of individual arms from the EXAM study that have been submitted are not suitable for drawing conclusions regarding additional benefit, as not all inclusion criteria relevant to the research question were met in the study.
• Furthermore, the bias resulting from the comparison of individual arms from different studies – in terms of both magnitude and direction – cannot be assessed even on the basis of the sensitivity analyses provided.
• Moreover, the observed effects are not so large that they cannot be explained solely by bias.
• Overall assessment
  • No suitable data are available for assessing the additional benefit of selpercatinib compared with the appropriate comparator therapy. Consequently, additional benefit is not proven.
  • Selpercatinib may represent a relevant treatment option in individual cases within the indicated therapeutic indication.

Courtesy translation only, please refer to the German original.