RETSEVMO (selpercatinib) - Thyroid cancer

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

As first-line treatment, in view of:

• evidence of superiority of RETSEVMO (selpercatinib) in relation to cabozantinib or vandetanib in terms of progression-free survival assessed by an independent review committee (HR = 0.280; 95% CI [0.165; 0.475], p<0.0001), in a randomised, open-label phase III study (LIBRETTO-531);
• safety deemed to be favourable;
• treatment considered to be similar for both adults and adolescents. As the studies (LIBRETTO and LIBRETTO-531) only included 3 adolescents, the efficacy data for adults have been accepted as suitable for extrapolation to adolescents 12 years and older,

and despite:

• the lack of evidence of an improvement in overall survival (non-ranked secondary outcome measure) during the interim analysis, in a context of advanced-stage disease with an unfavourable prognosis;
• the lack of formal conclusions that can be drawn from the exploratory quality-of-life findings;
• the findings available with a short follow-up period (median follow-up of 1 year at the interim analysis that has become the primary analysis);

the Committee deems that RETSEVMO (selpercatinib) 40 mg and 80 mg, hard capsules, provides minor clinical added value (CAV IV) in relation to vandetanib or cabozantinib, for the first-line treatment of adult and adolescent patients 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC).