RETSEVMO (selpercatinib) - Thyroid cancer (TC)

The Committee deems that the clinical benefit of RETSEVMO (selpercatinib) 40 mg and 80 mg hard capsules is substantial in the indication “as monotherapy for the first-line treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC)”.

As first-line treatment, considering:

• demonstration of a superiority of RETSEVMO (selpercatinib) compared to cabozantinib or vandetanib in terms of progression-free survival assessed by an independent review committee (HR = 0.280; CI_95% [0.165; 0.475], p<0.0001), in a phase 3, randomised, open-label trial (LIBRETTO-531);
• a safety judged to be favourable;
• management considered to be similar for adults and adolescents. Since the studies (LIBRETTO-001 and LIBRETTO-531) only included three adolescents, the efficacy data in adults were accepted as being extrapolable to adolescents 12 years and older;

and despite:

• the lack of evidence of an improvement in overall survival (non-ranked secondary endpoint)
  following the interim analysis, in a context of advanced disease with an unfavourable prognosis;
• the absence of any formal conclusion that can be drawn based on the exploratory quality of life findings;
• results available with a short follow-up period (median follow-up of 1 year on the interim analysis, which became the primary analysis);

the Committee deems that RETSEVMO (selpercatinib) provides a minor clinical added value (CAV IV) compared to vandetanib or cabozantinib in the first-line treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC).