Favourable opinion for reimbursement “as monotherapy for the first-line treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC)”.
Clinical Benefit
Low
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)”.
Clinical Added Value
no clinical added value
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; CI95% [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).
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