Selpercatinib (7) – Retsevmo®

• Clinical trials
  • The LIBRETTO-001 trial is a multicentre, single-arm, prospective basket trial that has been ongoing since 2017.

Adults with an advanced RET-fusion-positive solid tumour for whom treatment options that do not target RET offer only limited clinical benefit or have been exhausted

• The additional benefit is not proven.
• The pharmaceutical manufacturer has not identified any relevant studies comparing selpercatinib with the appropriate comparator therapy to demonstrate its additional benefit.
• Nor are there any data available that allow for an indirect comparison of selpercatinib with the specified appropriate comparator therapy.
• The LIBRETTO-001 study submitted by the pharmaceutical manufacturer does not allow for a comparison with the appropriate comparator therapy due to its single-arm design and is therefore not suitable for assessing the additional benefit of selpercatinib compared with the appropriate comparator therapy.
• The additional benefit of selpercatinib as monotherapy for the treatment of adult patients with an advanced RET-fusion-positive solid tumour, in whom treatment options not targeting RET offer only limited clinical benefit or have been exhausted, is not proven.
• Conclusion
  • There are no suitable data available for assessing the additional benefit of selpercatinib.
  • Consequently, there is no evidence of additional benefit from selpercatinib as monotherapy for the treatment of adults with an advanced RET-fusion-positive solid tumour, in whom treatment options not targeting RET offer only limited clinical benefit or have been exhausted, there is no proof that the appropriate comparator therapy offers better clinical outcomes than the treatment options.

Courtesy translation only, please refer to the German original.